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

To determine the safety and effectiveness of PEVAR.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: SEVAR (IntuiTrak); Device: PEVAR (ProGlide closure); Device: PEVAR (Prostar XL closure)

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92357
      • Loma Linda VA Medical Center
    • San Diego, California, United States, 92161
      • VA San Diego
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Medical Center
    • Gainesville, Florida, United States, 32608
      • VA Gainesville
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
    • Miami, Florida, United States, 33125
      • VA Miami
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60616
      • Mercy Hospital
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Forrest General Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Willoughby, Ohio, United States, 44094
      • Lake Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 93120
      • Oklahoma Heart Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Hospital
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Houston, Texas, United States, 77030
      • St. Luke's Hospital at Texas Heart Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard EVAR (IntuiTrak); EVAR using standard vascular exposure for access	Device: SEVAR (IntuiTrak); Standard vascular exposure for access prior to EVAR; Other Names: IntuiTrak
Experimental: PEVAR (ProGlide closure); Percutaneous EVAR facilitated by the ProGlide closure device	Device: PEVAR (ProGlide closure); Percutaneous EVAR facilitated by the ProGlide closure device; Other Names: IntuiTrak; ProGlide
Experimental: PEVAR (ProstarXL closure); Percutaneous EVAR facilitated by the Prostar XL closure device	Device: PEVAR (Prostar XL closure); Percutaneous EVAR facilitated by the Prostar XL closure device; Other Names: IntuiTrak; Prostar XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events	SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).	30 days
SF-36 (Health-related Quality of Life Survey)	Health-related Quality of Life per the standardized short form 36-item survey [SF-36]); self-reported groin pain per a Pain Scale. It comprises 36 questions which cover eight domains of health: Physical Function (Range 0 to 100); Social Functioning (Range 0 to 100); Role Limitations due to physical Health (Range o to 100); Pain (Range 0 to 100); Mental Health (Range 0 to 100); Role limitations due to emotional health (Range 0 to 100); Energy and fatigue (Range 0 to 100); General health (Range 0 to 100) Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	30 days
Clinical Utility Measures	In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.	From Procedure to Discharge Visit
Clinical Utility Measures	% requiring Foley catheter, central venous catheter, or gastric tube; % discharged to skilled nursing facility (SNFs) or assistive living facility (ALFs); % requiring analgesic for groin pain.	From Procedure to Discharge Visit
Number of Participants With All Non-serious Adverse Events	Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below.	30 Days
Clinical Utility Measure	In-hospital evaluations: Contrast media volume used	Through Pre-Discharge Visit
Clinical Utility Measures	In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.	During Procedure
Clinical Utility Measures	In-hospital evaluations: Times to possible and actual hospital discharge.	Through Pre-Discharge Visit

Collaborators and Investigators

• Sponsor: Endologix
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Edward B Diethrich, MD, Endologix

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2010
• Primary Completion (Actual): March 9, 2012
• Study Completion (Actual): September 5, 2012

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous; Stent graft; Endovascular; Preclose; Endologix; Abbott Vascular; PEVAR; Suture mediated closure devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP-0001