CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Endovascular abdominal aortic aneurysm repairdevice
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/NCT02477111
NCT02477111N/ACompleted
CompareCT.gov

A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms

Cordis US Corp.·observational·Posted Jun 22, 2015·Updated Apr 9, 2024

In Brief

An observational study evaluating Endovascular abdominal aortic aneurysm repair for Abdominal Aortic Aneurysms. Completed, enrolled 150 participants across 23 sites in 8 countries.

Detailed Summary

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Aortic Aneurysms
CountriesFrance, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 22, 2015
Enrollment StartMar 30, 2015
Primary CompletionOct 24, 2016
Study CompletionDec 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.0 years ago

Interventions

Endovascular abdominal aortic aneurysm repairdevice

Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.