The Merit WRAPSODYâ„¢ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease (NCT03994185) | Clinical Trial Compass
WithdrawnNot Applicable
The Merit WRAPSODYâ„¢ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
Stopped: Study was withdrawn by the Sponsor prior to enrollment
0Started 2020-09
Plain-language summary
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including lesions at the aortic bifurcation.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Subject has signed informed consent
✓. Subject is ≥ 21 years of age
✓. Subject is able and willing to comply with study requirements
✓. Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure
✓. Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4
✓. Angiographic evidence of de novo or restenotic target lesion(s) in native vessels in the common and/or external iliac artery(ies) (multiple stenoses may exist within the target lesion)
✓. Total lesion(s) length is ≤ 110mm
✓. Target lesion(s) is at least 3 cm from an existing stent or stent graft
Exclusion criteria
✕. Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) \<30 days from the date of the index study procedure
✕. Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
✕. Previous or planned bypass surgery in the target limb(s)
✕. Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
What they're measuring
1
Safety endpoint of subjects free from specified adverse events
Timeframe: 4 weeks after placement of WRAPSODY stent graft
2
Effectiveness endpoint of subjects with improvement of Rutherford Category
Timeframe: 4 weeks after placement of WRAPSODY stent graft
3
Effectiveness endpoint of subjects with patency
Timeframe: 4 weeks after placement of WRAPSODY stent graft