MedTrace Logo

Fenestrated AAA Endovascular Graft Post-Approval Study

NCT01990950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-10-05

Study results available
· View outcomes & findings →

Summary

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

Conditions

  • Abdominal Aortic Aneurysm (AAA)
  • Aorto-iliac Aneurysm
  • Juxtarenal Aneurysm

Interventions

DEVICE

Zenith® Fenestrated AAA Endovascular Graft

The Zenith® Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-10-12
Completion
2020-10-12

Countries

  • United States

Study Locations

More Related Trials

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 NCT01990950 on ClinicalTrials.gov