CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 195 enrolled
Drug / intervention
Anaconda Stent Graft System +1 moredevice
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/NCT00612924
NCT00612924N/ACompleted
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The Anaconda Endovascular Graft US FDA Phase II Clinical Study

Terumo CVS·interventional·Posted Feb 12, 2008·Updated Oct 16, 2017

In Brief

A clinical study evaluating Anaconda Stent Graft System and Anaconda ONE-LOK Stent Graft System for Infrarenal Abdominal Aortic Aneurysm. Completed, enrolled 195 participants across 23 sites in 2 countries.

Detailed Summary

The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfrarenal Abdominal Aortic Aneurysm
CountriesCanada, United States
CollaboratorsVascutek Ltd.

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2008
Enrollment StartApr 1, 2009
Primary CompletionJul 1, 2013
Study CompletionJul 13, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.4 years ago

Interventions

Anaconda Stent Graft Systemdevice

Endovascular device

Anaconda ONE-LOK Stent Graft Systemdevice

Endovascular device