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

NCT03994185 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

  • Stenosis of Artery
  • Peripheral Arterial Disease
  • Iliac Artery Disease
  • Iliac Artery Occlusion

Interventions

DEVICE

Placement of WRAPSODY stent graft

Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Holden · Auckland City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2020-09-30
Completion
2020-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994185 on ClinicalTrials.gov