Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysms
Treatment cordis aaa stent graft system "incraft tm"
Phase phase 2
Sponsor Cordis Corporation
Start date March 2010
End date August 2011
Trial size 60 participants
Trial identifier NCT01106391, EE09-01

Summary

This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms.

The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AAA stent graft system
cordis aaa stent graft system "incraft tm"

Primary Outcomes

Measure
Rate of Technical Success Through the One Month Follow up.
time frame: From procedure to one month follow up
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
time frame: One month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures. 2. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. The INCRAFT Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: 1. Adequate iliac/femoral access compatible with the required delivery systems 2. Non-aneurysmal proximal aortic neck, and 3. Non-aneurysmal distal iliac landing zone.

Additional Information

Official title A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
Principal investigator Dierk Scheinert, PhD, MD.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Cordis Corporation.