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Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00739401
Recruitment Status : Unknown
Verified September 2011 by Endologix.
Recruitment status was:  Active, not recruiting
First Posted : August 21, 2008
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: Suprarenal Proximal Cuff Extension Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endologix Powerlink® Suprarenal Proximal Cuff
Study Start Date : May 2006
Primary Completion Date : July 2008
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
Device: Suprarenal Proximal Cuff Extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft


Outcome Measures

Primary Outcome Measures :
  1. Proximal type I endoleak [ Time Frame: Within 30 Days ]

Secondary Outcome Measures :
  1. Major adverse events; delivery and deployment success, device integrity, patency, graft migration; and renal function. [ Time Frame: Within 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739401


Locations
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Munroe Regional Medical Center
Ocala, Florida, United States, 34474
Orlando Regional Hospital
Orlando, Florida, United States, 32806
Sacred Heart Hospital - Pensacola Research Consultants
Pensacola, Florida, United States, 32504
United States, Illinois
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
Deaconess Hospital - The Heart Group
Evansville, Indiana, United States, 47710
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
East Carolina University - Brody School of Medicine
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Endologix
Investigators
Principal Investigator: Robert Beasley, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: William M. Bogey, MD East Carolina University - Brody School of Medicine
Principal Investigator: Robert Feldman, MD Munroe Regional Medical Center
Principal Investigator: Stuart Harlin, MD Sacred Heart Hospital - Pensacola Research
Principal Investigator: Jeffrey Lawson, MD Duke University
Principal Investigator: William Moore, MD Lexington Medical Center
Principal Investigator: Charles Thompson, MD Orlando Regional Medical Center
Principal Investigator: Thomas E. Topper, MD Deaconess Hospital - The Heart Group
More Information

Additional Information:
Publications:
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT00739401     History of Changes
Other Study ID Numbers: CP04-002
IDE G990139
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: September 2011

Keywords provided by Endologix:
AAA
Aneurysm
Suprarenal
Proximal
Cuff
Extension
Endograft
Endovascular repair
EVAR
Endoleak
Type I

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases