CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Zenith® Fenestrated AAA Endovascular Graftdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01990950
NCT01990950N/ACompleted
CompareCT.gov

Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study

Cook Research Incorporated·interventional·Posted Nov 25, 2013·Updated Oct 5, 2021

In Brief

A clinical study evaluating Zenith® Fenestrated AAA Endovascular Graft for Abdominal Aortic Aneurysm (AAA) and 2 related conditions. Completed, enrolled 21 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartMar 1, 2014
Primary CompletionOct 12, 2020
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 12.6 years ago

Interventions

Zenith® Fenestrated AAA Endovascular Graftdevice

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