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Completed

NCT Number: NCT00739401

Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Endoleak Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Medical Center, Miami Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suprarenal Proximal Cuff Extension

Device

Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft

Primary outcomes

  1. Number of Subjects With Proximal Type I Endoleak

    Time frame: Within 30 Days

    The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.

Secondary outcomes

  1. Number of Subjects With Major Adverse Events

    Time frame: Within 30 days

    All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke

  2. Number of Participants With Stent Graft Integrity and Performance

    Time frame: 30 days

    Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results

  3. Endoleak

    Time frame: 30 days

    Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak.

    Endoleak diagnosis results as reported by the Core Lab.

  4. Aneurysm Morphology Changes

    Time frame: 30 days

    Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.

  5. Renal Function

    Time frame: 30 days

    Renal function as measured by serum creatinine. Laboratory results,

  6. Aneurysm Morphology Changes

    Time frame: 30 days

    Aneurysm morphology changes (Volume) as reported by CoreLab.

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study title

Endologix Powerlink® Suprarenal Proximal Cuff

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 21, 2008
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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