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A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries. (VBXFLEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02080871
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : July 17, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Stenting of the Common and/or External Iliac Arteries Not Applicable

Detailed Description:
This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.
Actual Study Start Date : July 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Gore VIABAHN BX
Balloon expandable stenting of iliac occlusive disease
Device: Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.




Primary Outcome Measures :
  1. Composite of Major Adverse Events (MAEs) [ Time Frame: 9 months ]
    Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.


Secondary Outcome Measures :
  1. Acute Procedural Success [ Time Frame: Discharge ]
    Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.

  2. 30-Day Clinical Success [ Time Frame: 30 Days ]
    Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.

  3. Percentage of Participants With Primary Patency [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of primary patency at 30 days.

  4. Percentage of Participants With Primary Patency [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of primary patency at 9 months.

  5. Percentage of Participants With Primary Assisted Patency [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of primary assisted patency at 30 days.

  6. Percentage of Participants With Primary Assisted Patency [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of primary assisted patency at 9 months.

  7. Percentage of Participants With Secondary Patency [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of secondary patency at 30 days.

  8. Percentage of Participants With Secondary Patency [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of secondary patency at 9 months.

  9. Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.

  10. Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.

  11. Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.

  12. Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.

  13. Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.

  14. Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.

  15. Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) [ Time Frame: 30 Days ]
    Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.

  16. Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) [ Time Frame: 9 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months

  17. Number of Participants With Change in Rutherford Category [ Time Frame: 30 Days ]

    Number of participants with change in Rutherford Category from pre-procedure at 30 days.

    Rutherford Categories:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene


  18. Number of Participants With Change in Rutherford Category [ Time Frame: 9 Months ]

    Number of participants with change in Rutherford Category from pre-procedure at 9 months.

    Rutherford Categories:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene


  19. Change in Ankle Brachial Index (ABI) [ Time Frame: 30 Days ]
    Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

  20. Change in Ankle Brachial Index (ABI) [ Time Frame: 9 Months ]
    Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

  21. Number of Participants With Change in Functional Status - EQ5D - Mobility [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.

  22. Number of Participants With Change in Functional Status - EQ5D - Mobility [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.

  23. Number of Participants With Change in Functional Status - EQ5D - Self Care [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.

  24. Number of Participants With Change in Functional Status - EQ5D - Self Care [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.

  25. Number of Participants With Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.

  26. Number of Participants With Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.

  27. Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.

  28. Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.

  29. Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.

  30. Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.

  31. Number of Participants With Change in Functional Status - EQ5D - Own Health State [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.

  32. Number of Participants With Change in Functional Status - EQ5D - Own Health State [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.

  33. Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ) [ Time Frame: 30 Days ]
    Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.

  34. Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ) [ Time Frame: 9 Months ]
    Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.

  35. Percentage of Participants With Primary Patency [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of primary patency at 12 months.

  36. Percentage of Participants With Primary Assisted Patency [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of primary assisted patency at 12 months.

  37. Percentage of Participants With Secondary Patency [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of secondary patency at 12 months.

  38. Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.

  39. Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 24 Months ]
    Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.

  40. Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 36 Months ]
    Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.

  41. Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.

  42. Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 24 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.

  43. Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 36 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.

  44. Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.

  45. Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 24 Months ]
    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.

  46. Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 36 Months ]
    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.

  47. Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) [ Time Frame: 12 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months

  48. Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) [ Time Frame: 24 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months

  49. Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) [ Time Frame: 36 Months ]
    Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months

  50. Number of Participants With Change in Rutherford Category [ Time Frame: 12 Months ]

    Number of participants with change in Rutherford Category from pre-procedure at 12 months.

    Rutherford Categories:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene


  51. Number of Participants With Change in Rutherford Category [ Time Frame: 24 Months ]

    Number of participants with change in Rutherford Category from pre-procedure at 24 months.

    Rutherford Categories:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene


  52. Number of Participants With Change in Rutherford Category [ Time Frame: 36 Months ]

    Number of participants with change in Rutherford Category from pre-procedure at 36 months.

    Rutherford Categories:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene


  53. Change in Ankle Brachial Index (ABI) [ Time Frame: 12 Months ]
    Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

  54. Change in Ankle Brachial Index (ABI) [ Time Frame: 24 Months ]
    Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

  55. Change in Ankle Brachial Index (ABI) [ Time Frame: 36 Months ]
    Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

  56. Number of Participants With Change in Functional Status - EQ5D - Mobility [ Time Frame: 12 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.

  57. Number of Participants With Change in Functional Status - EQ5D - Mobility [ Time Frame: 24 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.

  58. Number of Participants With Change in Functional Status - EQ5D - Mobility [ Time Frame: 36 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.

  59. Number of Participants With Change in Functional Status - EQ5D - Self Care [ Time Frame: 12 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.

  60. Number of Participants With Change in Functional Status - EQ5D - Self Care [ Time Frame: 24 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.

  61. Number of Participants With Change in Functional Status - EQ5D - Self Care [ Time Frame: 36 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.

  62. Number of Participants With Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 12 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.

  63. Number of Participants With Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 24 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.

  64. Number of Participants With Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 36 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.

  65. Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 12 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.

  66. Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 24 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.

  67. Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 36 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.

  68. Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 12 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.

  69. Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 24 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.

  70. Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 36 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.

  71. Number of Participants With Change in Functional Status - EQ5D - Own Health State [ Time Frame: 12 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.

  72. Number of Participants With Change in Functional Status - EQ5D - Own Health State [ Time Frame: 24 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.

  73. Number of Participants With Change in Functional Status - EQ5D - Own Health State [ Time Frame: 36 Months ]
    Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.


Other Outcome Measures:
  1. Device or Procedure-related Death [ Time Frame: 30 Days ]
    Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome

  2. Myocardial Infarction (MI) [ Time Frame: 30 Days ]
    Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome

  3. Target Lesion Revascularization (TLR) [ Time Frame: 9 Months ]
    Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome

  4. Major Amputation [ Time Frame: 9 Months ]
    Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is at least 18 years old;
  2. Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
  3. Patient or legal representative is willing to give written informed consent;
  4. Patient is capable of complying with protocol requirements, including all follow-up visits;
  5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
  6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
  7. Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
  8. Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
  9. Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
  10. Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
  11. Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
  12. Patient has the device advanced across the target lesion(s) and positioned for deployment.

Exclusion Criteria:

  1. Patient has a life expectancy of less than 1 year;
  2. Patient has a known allergy to stent graft components, including stainless steel or heparin;
  3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
  4. Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
  5. Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);
  6. Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
  7. Patient has a known hypercoagulability that cannot be corrected;
  8. Patient has evidence of a blood borne infection;
  9. Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
  10. Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
  11. Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
  12. Patient is currently participating in this or another investigative clinical study.
  13. Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
  14. Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
  15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
  16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
  17. Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080871


Locations
Show Show 27 study locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Layout table for investigator information
Principal Investigator: Jean Bismuth, MD The Methodist Hospital System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02080871    
Other Study ID Numbers: BES 10-07
First Posted: March 6, 2014    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: January 16, 2019
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by W.L.Gore & Associates:
PAD
Stent
Claudication
Viabahn
Gore
Endoprosthesis
Vascular Diseases
Cardiovascular Diseases
Iliac Occlusive Disease
Balloon Expandable
Stent-graft
VBX
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases