Multi-center Study for Stent Graft System for Peripheral Artery (NCT01575808) | Clinical Trial Compass
CompletedNot Applicable
Multi-center Study for Stent Graft System for Peripheral Artery
Japan133 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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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…