Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
PEVAR
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
1 other identifier
interventional
192
1 country
20
Brief Summary
To determine the safety and effectiveness of PEVAR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Typical duration for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedStudy Start
First participant enrolled
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2012
CompletedResults Posted
Study results publicly available
June 7, 2022
CompletedJune 7, 2022
March 1, 2022
1.9 years
February 16, 2010
June 23, 2014
June 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
The primary endpoint for the trial is 30-day Treatment Success, defined as the composite of the following as determined by the independent physician adjudicator: * Procedural technical success * Absence of vascular complication * Absence of major adverse event
30 days
Secondary Outcomes (8)
Number of Participants With Serious Adverse Events
30 days
SF-36 (Health-related Quality of Life Survey)
30 days
Clinical Utility Measures
From Procedure to Discharge Visit
Clinical Utility Measures
From Procedure to Discharge Visit
Number of Participants With All Non-serious Adverse Events
30 Days
- +3 more secondary outcomes
Study Arms (3)
Standard EVAR (IntuiTrak)
ACTIVE COMPARATOREVAR using standard vascular exposure for access
PEVAR (ProGlide closure)
EXPERIMENTALPercutaneous EVAR facilitated by the ProGlide closure device
PEVAR (ProstarXL closure)
EXPERIMENTALPercutaneous EVAR facilitated by the Prostar XL closure device
Interventions
Percutaneous EVAR facilitated by the ProGlide closure device
Standard vascular exposure for access prior to EVAR
Percutaneous EVAR facilitated by the Prostar XL closure device
Eligibility Criteria
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);
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endologixlead
- Abbott Medical Devicescollaborator
Study Sites (20)
Loma Linda VA Medical Center
Loma Linda, California, 92357, United States
VA San Diego
San Diego, California, 92161, United States
Holy Cross Medical Center
Fort Lauderdale, Florida, 33308, United States
VA Gainesville
Gainesville, Florida, 32608, United States
VA Miami
Miami, Florida, 33125, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Northwestern University
Chicago, Illinois, 60611, United States
Mercy Hospital
Chicago, Illinois, 60616, United States
Forrest General Hospital
Hattiesburg, Mississippi, 39401, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Lake Health
Willoughby, Ohio, 44094, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 93120, United States
North Central Heart Hospital
Sioux Falls, South Dakota, 57108, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
St. Luke's Hospital at Texas Heart Institute
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Inova Fairfax
Falls Church, Virginia, 22042, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (3)
Wang Q, Wu J, Ma Y, Zhu Y, Song X, Xie S, Liang F, Gimzewska M, Li M, Yao L. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev. 2023 Jan 11;1(1):CD010185. doi: 10.1002/14651858.CD010185.pub4.
PMID: 36629152DERIVEDNelson 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.
PMID: 24440678DERIVEDKrajcer 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.
PMID: 21796092DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elisa Hebb
- Organization
- Endologix
Study Officials
- PRINCIPAL INVESTIGATOR
Edward B Diethrich, MD
Endologix
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
April 13, 2010
Primary Completion
March 9, 2012
Study Completion
September 5, 2012
Last Updated
June 7, 2022
Results First Posted
June 7, 2022
Record last verified: 2022-03