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

W.L. Gore & Associates

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: GP1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01575808

JPS 16-02 / VJH11-01

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

GP1101

Experimental group

Description:

Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft

Treatment:

Device: GP1101

Retrospective Surgical Bypass Outcomes

No Intervention group

Description:

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.