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Absolute Pro® MOMENTUM™ (MOMENTUM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01444378
First received: September 21, 2011
Last updated: April 25, 2017
Last verified: April 2017
  Purpose

To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or the native proximal popliteal artery (PPA).

CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal (U.S.) law to investigational use only.


Condition Intervention
Peripheral Artery Disease Peripheral Vascular Disease Device: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems in the Treatment of Subjects With Atherosclerotic De Novo or Restenotic Lesions in the Native Superficial Femoral Artery and/or Native Proximal Popliteal Artery.

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Major Adverse Event (MAE) [ Time Frame: 30 days ]

    Primary safety endpoint is freedom from MAE which is defined as a composite of:

    • Death due to all causes
    • Index limb major amputation (at or above the ankle)
    • Clinically-driven target lesion revascularization (TLR)

  • Freedom From Vessel Patency [ Time Frame: 0 to 365 days ]
    This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.


Secondary Outcome Measures:
  • Acute Success : Device Success [ Time Frame: With in 2 days of index post procedure ]
    Device success defined on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.

  • Acute Success : Clinical Success [ Time Frame: With in 2 days after index post procedure or at hospital discharge (before 1 month) ]
    Clinical success: Defined on a per patient basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.

  • Acute Success : Technical Success [ Time Frame: With in 2 days of index post procedure ]
    Technical success: Device success plus attainment of final residual stenosis of < 30%

  • Freedom From Vessel Patency [ Time Frame: 0 to 30 days ]
    This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

  • Freedom From Vessel Patency [ Time Frame: 0 to 180 days ]
    This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

  • Ankle Brachial Index (ABI) for the Treated Limb [ Time Frame: Pre-Procedure ]

    A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

    A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.


  • Ankle Brachial Index (ABI) for the Treated Limb [ Time Frame: 1 month ]

    A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

    A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.


  • Ankle Brachial Index (ABI) for the Treated Limb [ Time Frame: 6 months ]

    A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

    A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.


  • Ankle Brachial Index (ABI) for the Treated Limb [ Time Frame: 12 months ]

    A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

    A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.


  • Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 month ]

    Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:

    • Worsening Rutherford-Becker Clinical Category;
    • Change in ABI by >0.15 and ABI ≤0.8

  • Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 6 months ]

    Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:

    • Worsening Rutherford-Becker Clinical Category;
    • Change in ABI by >0.15 and ABI ≤0.8

  • Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 year ]

    Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:

    • Worsening Rutherford-Becker Clinical Category;
    • Change in ABI by >0.15 and ABI ≤0.8

  • Any Target Lesion Revascularization (TLR) [ Time Frame: At 1 month ]
    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

  • Any Target Lesion Revascularization (TLR) [ Time Frame: At 6 months ]
    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

  • Any Target Lesion Revascularization (TLR) [ Time Frame: At 1 year ]
    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

  • Target Vessel Revascularization (TVR) [ Time Frame: At 1 month ]
    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.

  • Target Vessel Revascularization (TVR) [ Time Frame: At 6 months ]
    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.

  • Target Vessel Revascularization (TVR) [ Time Frame: At 1 year ]
    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.

  • Death [ Time Frame: At 1 month ]
  • Death [ Time Frame: At 6 months ]
  • Death [ Time Frame: At 1 year ]
  • Freedom From Stent Patency [ Time Frame: 0 to 30 days ]
    Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

  • Freedom From Stent Patency [ Time Frame: 0 to 180 days ]
    Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

  • Freedom From Stent Patency [ Time Frame: 0 to 365 days ]
    Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

  • Freedom From Stent Patency [ Time Frame: 0 to 379 days ]
    Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

  • Freedom From Any Ipsilateral Amputation [ Time Frame: At day 0 (on the day of index procedure) ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Any Ipsilateral Amputation [ Time Frame: 0 to 30 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Any Ipsilateral Amputation [ Time Frame: 0 to 180 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Any Ipsilateral Amputation [ Time Frame: 0 to 365 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Any Ipsilateral Amputation [ Time Frame: 0 to 379 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Embolic Events in the Treated Limb (as Reported by Site) [ Time Frame: At 1 month ]
    Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

  • Embolic Events in the Treated Limb (as Reported by Site) [ Time Frame: At 6 months ]
    Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

  • Embolic Events in the Treated Limb (as Reported by Site) [ Time Frame: At 1 year ]
    Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

  • Rutherford-Becker Clinical Category for the Treated Limb [ Time Frame: Pre-procedure ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category and Clinical Description:

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.


  • Rutherford-Becker Clinical Category for the Treated Limb [ Time Frame: 1 month ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category and Clinical Description:

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.


  • Rutherford-Becker Clinical Category for the Treated Limb [ Time Frame: 6 months ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category and Clinical Description:

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.


  • Rutherford-Becker Clinical Category for the Treated Limb [ Time Frame: 12 months ]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

    Category and Clinical Description:

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.


  • Walking Impairment Questionnaire Scores [ Time Frame: Pre-procedure ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Walking Impairment Questionnaire Scores [ Time Frame: 1 month ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Walking Impairment Questionnaire Scores [ Time Frame: 6 months ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Walking Impairment Questionnaire Scores [ Time Frame: 12 months ]
    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

  • Maximum Walking Distance [ Time Frame: Pre-procedure ]
  • Maximum Walking Distance [ Time Frame: 1 month ]
  • Maximum Walking Distance [ Time Frame: 6 months ]
  • Maximum Walking Distance [ Time Frame: 12 months ]
  • Stent Integrity by X-ray [ Time Frame: 12 months ]

    Xrays were performed to evaluate stent integrity and to determine the presence of any stent fractures.

    Grade of fracture as follows:

    0 - No stent fracture(s) identified

    1. - Single strut fracture only
    2. - Multiple strut fractures
    3. - Stent fracture with alignment
    4. - Fracture out of alignment (≥ 2 segments)
    5. - Spiral Fracture

  • Toe Brachial Index (TBI) [ Time Frame: At 1 month ]
    The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Toe Brachial Index (TBI) [ Time Frame: At 6 months ]
    The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Toe Brachial Index (TBI) [ Time Frame: At 1 year ]
    The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

  • Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV) [ Time Frame: 1 month ]

    In-Stent Restenosis:

    Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography.


  • Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV) [ Time Frame: 12 months ]

    In-Stent Restenosis:

    Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography.


  • Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR) [ Time Frame: 1 month ]
    In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.

  • Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR) [ Time Frame: 12 months ]
    In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.

  • Acute Stent Thrombosis [ Time Frame: 0 - 24 Hours Post Study Procedure ]
    Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.

  • Sub-Acute Stent Thrombosis [ Time Frame: > 24 Hours - 30 Days Post Study Procedure ]
    Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.

  • Stent Occlusion [ Time Frame: > 30 Days Post Study Procedure ]
    Stent occlusion was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs > 30 days post-index procedure.

  • In-Segment Percent Diameter Stenosis (%DS) [ Time Frame: Pre-Procedure ]

    Percent Diameter Stenosis:

    The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.


  • In-Segment Percent Diameter Stenosis (%DS) [ Time Frame: Post-Procedure (≥ 1 day) ]

    Percent Diameter Stenosis:

    The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.


  • In-Stent Percent Diameter Stenosis (%DS) [ Time Frame: Post-Procedure (≥ 1 day) ]

    Percent Diameter Stenosis:

    The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.


  • Freedom From Ipsilateral Major Amputation [ Time Frame: At day 0 (on the day of index procedure) ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Ipsilateral Major Amputation [ Time Frame: 0 to 30 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Ipsilateral Major Amputation [ Time Frame: 0 to 180 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Ipsilateral Major Amputation [ Time Frame: 0 to 365 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Freedom From Ipsilateral Major Amputation [ Time Frame: 0 to 379 days ]
    Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

  • Quality of Life Measures : Physical Functioning (PF) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Physical Functioning (PF) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Physical Functioning (PF) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Role Physical (RP) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Role Physical (RP) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Role Physical (RP) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Bodily Pain (BP) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Bodily Pain (BP) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Bodily Pain (BP) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : General Health (GH) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : General Health (GH) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : General Health (GH) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Vitality (VT) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Vitality (VT) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Vitality (VT) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Social Functioning (SF) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Social Functioning (SF) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Social Functioning (SF) [ Time Frame: 1 year ]

    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

    rm-Based Scores.


  • Quality of Life Measures : Role Emotional (RE) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Role Emotional (RE) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Role Emotional (RE) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Mental Health (MH) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Mental Health (MH) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Mental Health (MH) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Physical Component Summary (PCS) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Physical Component Summary (PCS) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Physical Component Summary (PCS) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Mental Component Summary (MCS) [ Time Frame: 1 month ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Mental Component Summary (MCS) [ Time Frame: 6 months ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Quality of Life Measures : Mental Component Summary (MCS) [ Time Frame: 1 year ]
    SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

  • Vascular Quality of Life (VascuQol) Total Scores [ Time Frame: 1 month ]

    Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.

    There are no sub scales.


  • Vascular Quality of Life (VascuQol) Total Scores [ Time Frame: 6 months ]
    Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.

  • Vascular Quality of Life (VascuQol) Total Scores [ Time Frame: 1 year ]
    Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.


Enrollment: 141
Study Start Date: October 2011
Study Completion Date: May 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Absolute Pro® and Pro LL® Peripheral Stent Systems Device: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems
Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Clinical Inclusion Criteria:

  1. Subject is ≥ 18 years of age.
  2. Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
  3. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
  4. Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).
  5. Female subject of childbearing potential must:

    • have had a negative pregnancy test (serum HCG) within 14 days before treatment;
    • not be nursing at the time of treatment; and
    • agree at time of consent to use birth control during participation in this trial.
  6. Subject has life expectancy > 12 months.

Angiographic Inclusion Criteria:

  1. A single de novo or restenotic [not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above the proximal margin of the intercondylar fossa.
  2. Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.
  3. Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.
  4. Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.
  5. A patent ipsilateral iliac artery, defined as < 50% stenosis, as confirmed by arteriography.
  6. At least one patent distal outflow artery (anterior tibial, posterior tibial, peroneal) defined as < 50% stenosis, that provides in-line circulation to the lower leg and foot.
  7. Total occlusion length ≤ 8 cm.

General Clinical Exclusion Criteria:

  1. Subject is unable to walk.
  2. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
  3. Subject has received, or is on the waiting list for, a major organ transplant.
  4. Subject is diagnosed as Rutherford-Becker Clinical Category 5 or 6 in either extremity.
  5. Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the target extremity (i.e., where the investigational stent will be placed).
  6. Subject has elevated serum creatinine > 2.5 mg/dl.
  7. Subject is on chronic hemodialysis.
  8. Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1c has been assessed as < 7.0% within 3 months prior to index procedure.
  9. Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
  10. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.
  11. Subject has unstable angina defined as rest angina with ECG changes.
  12. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
  13. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
  14. Subject is unable to take required antiplatelet therapy or requires any planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel, ticagrelor or ticlopidine within 30 days following the procedure.
  15. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 1 year.
  16. Subject is currently participating in an investigational drug, biologic, or device study.
  17. Subject is unable to understand or unwilling to cooperate with study procedures.
  18. Subject is allergic to nickel, titanium, platinum, contrast media, or any study-required medication that is not amenable to pre-treatment.
  19. Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hgb < 8.0) that cannot be corrected.
  20. Subject requires general anesthesia for the procedure.
  21. Subject has ischemic or neuropathic ulcers on either foot.
  22. Subject has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than of the toe or forefoot.
  23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

  1. Total occlusion of the ipsilateral iliac artery.
  2. Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.
  3. Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
  4. Target vessel has an angiographically significant (> 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.
  5. Target vessel has been previously treated at any location with a stent, or has been previously treated ≤ 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.
  6. Target lesion is within or adjacent to an aneurysm.
  7. Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.
  8. Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.
  9. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.
  10. Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.
  11. .Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.
  12. Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444378

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Bruce H. Gray, DO University Medical Center Greenville
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01444378     History of Changes
Other Study ID Numbers: 10-110
Study First Received: September 21, 2011
Results First Received: September 26, 2016
Last Updated: April 25, 2017

Keywords provided by Abbott Vascular:
Atherosclerosis
Claudication
Peripheral Arterial Occlusive Disease
Stent

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 21, 2017