Multi-center Study for Stent Graft System for Peripheral Artery
This trial is active, not recruiting.
|Condition||peripheral arterial disease|
|Phase||phase 2/phase 3|
|Sponsor||W.L.Gore & Associates|
|Start date||April 2012|
|End date||August 2014|
|Trial size||142 participants|
|Trial identifier||NCT01575808, VJH 11-01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Nagoya, Japan||Nagoya University Hospital||no longer recruiting|
|Nagano, Japan||Shinshu University Hospital||no longer recruiting|
|Matsuyama, Japan||Matsuyama Red Cross Hospital||no longer recruiting|
|Kitakyushu, Japan||Kokura Memorial Hospital||no longer recruiting|
|Sapporo, Japan||Tokeidai Memorial Hospital||no longer recruiting|
|Amagasaki, Japan||Kansai Rousai Hospital||no longer recruiting|
|Kobe, Japan||Kobe University Hospital||no longer recruiting|
|Kobe, Japan||Kobe Rosai Hospital||no longer recruiting|
|Nishinomiya, Japan||Hyogo College of Medicine Hospital||no longer recruiting|
|Kanazawa, Japan||National Hospital Organaization Kanazawa Medical Center||no longer recruiting|
|Sendai, Japan||Sendai Kousei Hospital||no longer recruiting|
|Kishiwada, Japan||Kishiwada Tokushukai Hospital||no longer recruiting|
|Suita, Japan||National Cerebral and Cardiovascular Center||no longer recruiting|
|Nara, Japan||Nara Medical University Hospital||no longer recruiting|
|Tokyo, Japan||Jikei Medical University Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
Primary Assisted Patency
time frame: one year
Safety and Efficacy
time frame: five years
Male or female participants at least 20 years old.
- 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
- 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.3
- 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
|Official title||The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease|
|Principal investigator||Takao Ohki, MD|
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