Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial (PEVAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070069
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : January 29, 2014
Abbott Vascular
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: PEVAR (ProGlide closure) Device: SEVAR (IntuiTrak) Device: PEVAR (Prostar XL closure) Phase 2

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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 Name: 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

Primary Outcome Measures :
  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 CEC. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. All serious and non-serious adverse events [ Time Frame: 30 days ]
  2. Stent graft patency and integrity [ Time Frame: 30 days ]
  3. Health-related Quality of Life Survey [ Time Frame: 30 days ]
  4. Clinical utility measures [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01070069

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Endologix Identifier: NCT01070069     History of Changes
Other Study ID Numbers: CP-0001
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Endologix:
Abbott Vascular
Stent graft
Suture mediated closure devices

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases