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

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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

This study is ongoing, but not recruiting participants.

Study NCT00706394. Last updated on June 26, 2008. Information provided by Endologix

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Abdominal Aortic Aneurysm

Intervention ^†

Device: Endologix Powerlink 34 mm stent graft cuff

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

September 2005

Completion Date

September 2012

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00706394

Organization ID

CP03-023

Secondary IDs ^††

Study Sponsor ^†

Endologix

Collaborators ^††

Investigators ^†

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

June 2008

First Received Date ^†

May 2, 2008

Last Updated Date

June 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.