Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03994185

The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease

Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Merit Medical Systems, Inc. · Industry
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Detailed description

Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically necessary, The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure. The primary clinical effectiveness endpoint is the proportion of subjects with a composite improvement of at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after index procedure.

Conditions

Interventions

TypeNameDescription
DEVICEPlacement of WRAPSODY stent graftPlacement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.

Timeline

Start date
2020-09-01
Primary completion
2020-09-01
Completion
2020-12-31
First posted
2019-06-21
Last updated
2020-04-24

Regulatory

Source: ClinicalTrials.gov record NCT03994185. Inclusion in this directory is not an endorsement.