Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

NCT ID: NCT01070069

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-13
• Study Completion Date: 2012-09-05

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard EVAR (IntuiTrak)

EVAR using standard vascular exposure for access

Group Type: ACTIVE_COMPARATOR

SEVAR (IntuiTrak)

Intervention Type: DEVICE

Standard vascular exposure for access prior to EVAR

PEVAR (ProGlide closure)

Percutaneous EVAR facilitated by the ProGlide closure device

Group Type: EXPERIMENTAL

PEVAR (ProGlide closure)

Intervention Type: DEVICE

Percutaneous EVAR facilitated by the ProGlide closure device

PEVAR (ProstarXL closure)

Percutaneous EVAR facilitated by the Prostar XL closure device

Group Type: EXPERIMENTAL

PEVAR (Prostar XL closure)

Intervention Type: DEVICE

Percutaneous EVAR facilitated by the Prostar XL closure device

Interventions

PEVAR (ProGlide closure)

Percutaneous EVAR facilitated by the ProGlide closure device

Intervention Type: DEVICE

SEVAR (IntuiTrak)

Standard vascular exposure for access prior to EVAR

Intervention Type: DEVICE

PEVAR (Prostar XL closure)

Percutaneous EVAR facilitated by the Prostar XL closure device

Intervention Type: DEVICE

Other Intervention Names

IntuiTrak; ProGlide; IntuiTrak; IntuiTrak; Prostar XL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward B Diethrich, MD

Role: PRINCIPAL_INVESTIGATOR

Endologix

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36629152 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24440678 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21796092 (View on PubMed)

Other Identifiers

CP-0001

Identifier Type: -

Identifier Source: org_study_id