This trial is active, not recruiting.

Condition peripheral arterial disease
Treatment gp1101
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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
Endovascular Device Implantation

Primary Outcomes

Primary Assisted Patency
time frame: one year

Secondary Outcomes

Safety and Efficacy
time frame: five years

Eligibility Criteria

Male or female participants at least 20 years old.

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.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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.