Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Treatment suprarenal proximal cuff extension
Phase phase 2
Sponsor Endologix
Start date May 2006
End date July 2008
Trial size 44 participants
Trial identifier NCT00739401, CP04-002, IDE G990139

Summary

The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
suprarenal proximal cuff extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft

Primary Outcomes

Measure
Proximal type I endoleak
time frame: Within 30 Days

Secondary Outcomes

Measure
Major adverse events; delivery and deployment success, device integrity, patency, graft migration; and renal function.
time frame: Within 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years old - Informed consent understood and signed - Will comply with post-treatment follow-up requirements up to 5 years - Candidate for Powerlink Infrarenal Bifurcated Graft Exclusion Criteria: - Life expectancy < 2 years - Participating in another clinical research study - Pregnant or lactating women - Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study - Creatinine level > 1.7mg/dl - Renal transplant patient - Patient with > 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation

Additional Information

Official title Endologix Powerlink® Suprarenal Proximal Cuff
Principal investigator Robert Beasley, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Endologix.