Clinical trial NCT01070069: Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
Official title: Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Percutaneous
Preclose
Endologix
Abbott Vascular
Endovascular
PEVAR
Stent graft
Suture mediated closure devices
Lead sponsor: Endologix
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Devices
First posted: 2010-02-17
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and effectiveness of PEVAR.

Detailed description: In \>30 single center publications, percutaneous EVAR facilitated with the Prostar XL or ProGlide closure has been demonstrated to be feasible. To date, no multicenter, randomized controlled trials of the approach are available. Moreover, although the IntuiTrak System and the closure devices are commercially available in the US as FDA-approved devices, no EVAR device and no closure device is FDA approved for a totally percutaneous EVAR application.

The IntuiTrak System is indicated for the treatment of abdominal aortic aneurysms with aortic necks ranging in size from 18mm to 32mm. The System includes a 19Fr integrated introducer sheath, which is designed to reduce exchanges, and may be particularly important in a percutaneous approach. Moreover, the device is the only currently approved EVAR device with a contralateral percutaneous (9Fr) indication.

Patients with abdominal aortic aneurysm who are suitable candidates for endovascular repair using the IntuiTrak System and who meet the prospectively defined inclusion/exclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 2:1. Physicians who are established experts in the field of percutaneous EVAR will participate in the trial.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC).
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: 30 days
measure: SF-36 (Health-related Quality of Life Survey)
timeFrame: 30 days
measure: Clinical Utility Measures
timeFrame: From Procedure to Discharge Visit
measure: Clinical Utility Measures
timeFrame: From Procedure to Discharge Visit
measure: Number of Participants With All Non-serious Adverse Events
timeFrame: 30 Days
measure: Clinical Utility Measure
timeFrame: Through Pre-Discharge Visit
measure: Clinical Utility Measures
timeFrame: During Procedure
measure: Clinical Utility Measures
timeFrame: Through Pre-Discharge Visit
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda VA Medical Center
state: California
city: San Diego
country: United States
facility: VA San Diego
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Medical Center
state: Florida
city: Gainesville
country: United States
facility: VA Gainesville
state: Florida
city: Miami
country: United States
facility: VA Miami
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital
state: Illinois
city: Hattiesburg
country: United States
facility: Forrest General Hospital
state: Mississippi
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Willoughby
country: United States
facility: Lake Health
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Sioux Falls
country: United States
facility: North Central Heart Hospital
state: South Dakota
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: St. Luke's Hospital at Texas Heart Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Endologix
name: Edward B Diethrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.
citation: Krajcer Z, Nelson P, Bianchi C, Rao V, Morasch M, Bacharach J. Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes from the first prospective, multicenter trial. J Cardiovasc Surg (Torino). 2011 Oct;52(5):651-9. Epub 2011 Jul 28.