CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Zenith(R) Low Profile AAA Endovascular Graftdevice
Likely dose
Zenith® Low Profile AAA Endovascular Graft endovascular deploymentAI-extracted
Key inclusion· 2
  • Abdominal aortic, aorto-iliac, or iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair
Key exclusion· 4
  • Age less than 18 years
  • Inability or refusal to provide informed consent
  • Medical conditions that would compromise patient safety or study outcomes
  • Unsuitable arterial anatomy for endovascular repair

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

Search/NCT00833924
NCT00833924N/ACompleted

Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

Cook Group Incorporated·interventional·Posted Feb 2, 2009·Updated Apr 4, 2018

In Brief

A clinical study evaluating Zenith(R) Low Profile AAA Endovascular Graft for Abdominal Aortic Aneurysms and 2 related conditions. Completed, enrolled 120 participants across 27 sites in 5 countries.

Detailed Summary

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Germany, Russia, Sweden, United States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2, 2009
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2011
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.4 years ago

Interventions

Zenith(R) Low Profile AAA Endovascular Graftdevice

The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.