34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms - Tabular View

Tracking Information

First Received Date ^ICMJE

May 2, 2008

Last Updated Date

August 4, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proximal Type I endoleak [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00706394 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Delivery success, deployment success, stent graft apposition to the vessel wall, device integrity, patency, occlusion, migration and Type III endoleak. [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Official Title ^ICMJE

Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Brief Summary

The 34mm proximal cuff extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Abdominal Aortic Aneurysm

Intervention ^ICMJE

Device: Endologix Powerlink 34 mm stent graft cuff

Study Arms / Comparison Groups

Experimental: Powerlink 34mm cuff stent graft

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2012

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years old or older
Informed consent understood and signed
Will comply with protocol follow-up requirements
Candidate for conventional open surgical repair
Aneurysm outer diameter is one or more of the following:
- greater than or equal to 4.0cm
- greater than or equal to 3.0cm (saccular aneurysm)
- greater than or equal to twice the normal aortic outer diameter
- rapidly growing (greater than or equal to 5mm over 6 months)
Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
Iliac artery internal diameter greater than or equal to 8 mm

Exclusion Criteria:

Life expectancy <2 years
Participating in another clinical study
Pregnant or lactating women
Acutely ruptured/leaking aneurysm
Traumatic vascular injury
Other medical or psychiatric problems
Contraindication to non-ionic contrast media or anticoagulants
Coagulopathy or bleeding disorder
Active systemic or localized groin infection
Indispensable inferior mesenteric artery
Connective tissue disease (e.g., Marfan's Syndrome)
Creatinine level >1.7 mg/dl
Renal transplant patient
Proximal attachment site >60º angle to the aneurysm body
Iliac arteries >90º angle
<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent]
Thrombus >30% at implantation site

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00706394

Responsible Party

Janet Fauls / VP, Regulatory, Quality, and Clinical Affairs, Endologix

Study ID Numbers ^ICMJE

CP03-023

Study Sponsor ^ICMJE

Endologix

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Edward Y Woo, MD	Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States
Principal Investigator:	O. W. Brown, MD	William Beaumont Hospital, Royal Oak, MI 48073, United States
Principal Investigator:	James G. Melton, DO	Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States
Principal Investigator:	Steven H. Tyndall, MD	Nebraska Heart Hospital, Lincoln, NE 68526, United States
Principal Investigator:	William M. Moore, MD	Lexington Medical Center, West Columbia, SC 29169, United States
Principal Investigator:	Salem George, MD	Baptist Hospital East, Louisville, KY 40207, United States
Principal Investigator:	Kerry C. Prewitt, MD	St. Joseph Medical Center, Towson, MD 21204, United States
Principal Investigator:	Paul Anain, MD	Sisters of Charity Hospital, Buffalo, NY 14214, United States
Principal Investigator:	Robert Beasley, MD	Mount Sinai Medical Center, Miami Beach, FL 33140, United States
Principal Investigator:	Barry T. Katzen, MD	Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States

Information Provided By

Endologix

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP