Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Endologix.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT00739401
First received: August 19, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Abdominal Aortic Aneurysm
Device: Suprarenal Proximal Cuff Extension
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endologix Powerlink® Suprarenal Proximal Cuff

Resource links provided by NLM:


Further study details as provided by Endologix:

Primary Outcome Measures:
  • Proximal type I endoleak [ Time Frame: Within 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse events; delivery and deployment success, device integrity, patency, graft migration; and renal function. [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: May 2006
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Mount Sinai School of Medicine
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
Study First Received: August 19, 2008
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014