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Multi-center Study for Stent Graft System for Peripheral Artery (VJH11-01)

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: NCT01575808
Recruitment Status : Active, not recruiting
First Posted : April 11, 2012
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: GP1101 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease
Study Start Date : April 2012
Actual Primary Completion Date : August 2014
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: GP1101
Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
Device: GP1101
Endovascular stent graft implantation
Other Name: Gore VIABAHN Endoprosthesis
No Intervention: Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion werer established to be consistent with the experimental arm.



Primary Outcome Measures :
  1. Primary Assisted Patency [ Time Frame: 12 months ]

    Primary Efficacy Endpoint >

    > Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion


  2. Duration of Stay [ Time Frame: Up to discharge ]
    Duration (in days) of post-procedure hospital stay

  3. Rate of Avoidance of General Anesthesia [ Time Frame: Day 0 ]
    Percentage of study subjects avoiding general anesthesia


Secondary Outcome Measures :
  1. Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb) [ Time Frame: 1 month ]
    Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure.

  2. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 1 month ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  3. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 3 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months.

  4. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 6 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  5. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 12 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  6. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 24 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  7. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 36 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  8. Percent of Participants Not Experiencing an Adverse Event [ Time Frame: 48 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  9. Rate of Avoidance of Adverse Events [ Time Frame: 60 months ]
    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  10. Technical Success [ Time Frame: Post-procedure ]
    Placement of GP1101 with residual stenosis of less than 30%

  11. Primary Patency [ Time Frame: 1 month ]
    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  12. Primary Patency [ Time Frame: 3 months ]
    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  13. Primary Patency [ Time Frame: 6 months ]
    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  14. Primary Patency [ Time Frame: 12 months ]
    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  15. Primary Patency [ Time Frame: 24 months ]
    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  16. Secondary Patency [ Time Frame: 1 month ]
    No bypass surgery and no occlusion at the target site

  17. Secondary Patency [ Time Frame: 3 months ]
    No bypass surgery and no occlusion at the target site

  18. Secondary Patency [ Time Frame: 6 months ]
    No bypass surgery and no occlusion at the target site

  19. Secondary Patency [ Time Frame: 12 months ]
    No bypass surgery and no occlusion at the target site

  20. Secondary Patency [ Time Frame: 24 months ]
    No bypass surgery and no occlusion at the target site

  21. Rate of Avoidance of Stent Fracture [ Time Frame: 1 month ]
    X-ray for stent fracture evaluated by Core Lab

  22. Rate of Avoidance of Stent Fracture [ Time Frame: 3 months ]
    X-ray for stent fracture evaluated by Core Lab

  23. Rate of Avoidance of Stent Fracture [ Time Frame: 6 months ]
    X-ray for stent fracture evaluated by Core Lab

  24. Rate of Avoidance of Stent Fracture [ Time Frame: 12 months ]
    X-ray for stent fracture evaluated by Core Lab

  25. Rate of Avoidance of Stent Fracture [ Time Frame: 24 months ]
    X-ray for stent fracture evaluated by Core Lab

  26. Avoidance of Target Lesion Revascularization [ Time Frame: 1 month ]
  27. Avoidance of Target Lesion Revascularization [ Time Frame: 3 months ]
  28. Avoidance of Target Lesion Revascularization [ Time Frame: 6 months ]
  29. Avoidance of Target Lesion Revascularization [ Time Frame: 12 months ]
  30. Avoidance of Target Lesion Revascularization [ Time Frame: 24 months ]
  31. Clinical Success [ Time Frame: 1 month ]

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication 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

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.


  32. Clinical Success [ Time Frame: 3 months ]

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication 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

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.


  33. Clinical Success [ Time Frame: 6 months ]

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication 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

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.


  34. Clinical Success [ Time Frame: 12 months ]

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication 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

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.


  35. Clinical Success [ Time Frame: 24 months ]

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication 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

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.


  36. Change in Ankle-Brachial Index From Baseline [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented ]
    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),

  37. Change in Ankle-Brachial Index From Baseline [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented ]
    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  38. Change in Ankle-Brachial Index From Baseline [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented ]
    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  39. Change in Ankle-Brachial Index From Baseline [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented ]
    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  40. Change in Ankle-Brachial Index From Baseline [ Time Frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented ]
    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  41. Vascular Quality of Life Questionnaire - VascuQOL [ Time Frame: 1 month ]
    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  42. Vascular Quality of Life Questionnaire - VascuQOL [ Time Frame: 3 months ]
    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  43. Vascular Quality of Life Questionnaire - VascuQOL [ Time Frame: 6 months ]
    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  44. Vascular Quality of Life Questionnaire - VascuQOL [ Time Frame: 12 months ]
    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  45. Vascular Quality of Life Questionnaire - VascuQOL [ Time Frame: 24 months ]
    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  46. Walking Impairment Questionnaire-WIQ [ Time Frame: 1 month ]
    WIQ Distance Score - Higher score reflects a better quality of life(Scores range: 0 to 100.)The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  47. Walking Impairment Questionnaire-WIQ [ Time Frame: 3 months ]
    WIQ Distance Score - Higher score reflects a better quality of life(Scores range: 0 to 100.)The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  48. Walking Impairment Questionnaire-WIQ [ Time Frame: 6 months ]
    WIQ Distance Score - Higher score reflects a better quality of life(Scores range: 0 to 100.)The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  49. Walking Impairment Questionnaire-WIQ [ Time Frame: 12 months ]
    WIQ Distance Score - Higher score reflects a better quality of life(Scores range: 0 to 100.)The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  50. Walking Impairment Questionnaire-WIQ [ Time Frame: 24 months ]
    WIQ Distance Score - Higher score reflects a better quality of life(Scores range: 0 to 100.)The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  51. Rate of Avoidance of Blood Transfusion [ Time Frame: Post-Procedure ]


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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rutherford 2-5 category
  • Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB).
  • At least 20 years of age.
  • Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.5.
  • Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure.
  • Projected life expectancy of greater than 2 years.
  • The ability to comply with the study protocol, follow-up requirements and required testing.
  • Surgical bypass candidate
  • Qualifying lesions by angiography

Exclusion Criteria:

  • Untreated flow-limiting aortoiliac disease.
  • Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery).
  • Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment.
  • Planned surgery or intervention within 30 days after study procedure.
  • Femoral artery or popliteal artery aneurysm > 1.5 X healthy adjacent vessel diameter.
  • Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis).
  • Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.)
  • Any medical condition that would preclude post-procedural ambulation or completion of study follow-up.
  • Rutherford 5 patients with active infection.
  • Serum creatinine >2.5 mg/dL within 30 days prior to study procedure.
  • Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level.
  • Rutherford 5 characteristics in non-study limb.
  • Major distal amputation (above the transmetatarsal) in the study or non-study limb.
  • Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia.
  • Any previously known coagulation disorder, including hypercoagulability.
  • Morbid obesity or operative scarring that precludes percutaneous approach
  • Contraindication to anticoagulation or antiplatelet
  • Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.
  • Current peritoneal or hemodialysis
  • Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment.
  • Enrollment in a F/P device clinical trial within the last 12 months.
  • Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months.
  • Any other factor identified by the Principal Investigator

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): NCT01575808


Locations
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Shinshu University Hospital
Nagano, Asahi, Matsumoto, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790-8524
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Tokeidai Memorial Hospital
Sapporo, Hokkaido, Japan, 060-0031
Kansai Rousai Hospital
Amagasaki, Hyogo, Japan, 660-8511
Kobe University Hospital
Kobe, Hyogo, Japan, 650-0017
Kobe Rosai Hospital
Kobe, Hyogo, Japan, 651-0053
Hyogo College of Medicine Hospital
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organaization Kanazawa Medical Center
Kanazawa, Ishikawa, Japan, 920-8650
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 980-0873
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan, 596-8522
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Nara Medical University Hospital
Nara, Japan, 634-8522
Jikei Medical University Hospital
Tokyo, Japan
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Takao Ohki, MD Jikei Medical University Hospital

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01575808     History of Changes
Other Study ID Numbers: VJH11-01
First Posted: April 11, 2012    Key Record Dates
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by W.L.Gore & Associates:
Symptomatic PAD
Stenosis
Occlusion

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