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

Sponsored by:	Endologix
Information provided by:	Endologix
ClinicalTrials.gov Identifier:	NCT00706394

Purpose

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.

Condition	Intervention	Phase
Abdominal Aortic Aneurysm	Device: Endologix Powerlink 34 mm stent graft cuff	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Endologix:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	60
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Powerlink 34mm cuff stent graft	Device: Endologix Powerlink 34 mm stent graft cuff Endovascular abdominal aortic aneurysm repair

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706394

Locations

United States, Florida
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Mount Sinai Medical Center
Miami, Florida, United States, 33140
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Maryland
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
United States, New York
Sisters of Charity Hospital
Buffalo, New York, United States, 14214
United States, Oklahoma
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Lexington Medical Center
West Columbia, South Carolina, United States, 29169

Sponsors and Collaborators

Endologix

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

More Information

No publications provided

Responsible Party:	Endologix ( Janet Fauls / VP, Regulatory, Quality, and Clinical Affairs )
Study ID Numbers:	CP03-023
Study First Received:	May 2, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00706394 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Endologix:

Powerlink
34mm
Abdominal Aortic Aneurysm
EVAR

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Aortic Aneurysm
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on July 02, 2009