Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm

In brief

To determine the safety and effectiveness of PEVAR.

Key facts

Study ID

NCT01070069

Run by

Endologix

People needed

192

Starts

2010-04-13

Expected to finish

2012-09-05

Last updated by the study team

2022-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female at least 18 years old
• Informed consent form understood and signed and patient agrees to all follow-up visits
• Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months
• Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol
• Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)

You may not qualify if…

• Life expectancy <1 year as judged by the investigator;
• Psychiatric or other condition that may interfere with the study;
• Participating in the enrollment or 30-day follow-up phase of another clinical study;
• Known allergy to any device component;
• Coagulopathy or uncontrolled bleeding disorder;
• Ruptured, leaking, or mycotic aneurysm;
• Serum creatinine (S-Cr) level >1.7 mg/dL;
• Traumatic vascular injury;
• Active systemic or localized groin infection;
• Connective tissue disease (e.g., Marfan's Syndrome);
• Renal transplant patient;
• Recent (within prior three months) cerebrovascular accident or myocardial infarction;
• Planned major intervention or surgery within 30 days following the EVAR procedure;
• Requirement for an arterial conduit at the access site;
• Morbidly obese (BMI≥40);
• Calcification throughout the common femoral artery (CFA) target area anterior wall or circumferentially or over >50% of the posterior wall;
• Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm;
• Evidence of prior common femoral artery surgery (e.g., groin incision);
• Prior clip-based vascular closure device placement in either arterial access site;
• Collagen-based vascular closure device placement in either arterial access site within the prior 90 days;
• Femoral artery needle puncture in either arterial access site within the prior 30 days;
• Hematoma at the ipsilateral arterial access site
• Significant scarring at the ipsilateral arterial access site

Where it is running

• Loma Linda VA Medical Center — Loma Linda, California, United States
• VA San Diego — San Diego, California, United States
• Holy Cross Medical Center — Fort Lauderdale, Florida, United States
• VA Gainesville — Gainesville, Florida, United States
• VA Miami — Miami, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Mercy Hospital — Chicago, Illinois, United States
• Forrest General Hospital — Hattiesburg, Mississippi, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Mission Hospital — Asheville, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Lake Health — Willoughby, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• North Central Heart Hospital — Sioux Falls, South Dakota, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• St. Luke's Hospital at Texas Heart Institute — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Fairfax — Falls Church, Virginia, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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