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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

NCT02489539 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-08-13

Study results available
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Summary

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

GORE® EXCLUDER® Conformable AAA Endoprosthesis

Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Robert Rhee, MD · Maimonides Medical Center (US)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2023-05-25
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02489539 on ClinicalTrials.gov