Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

Brief Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 All serious and non-serious adverse events

Condition

Abdominal Aortic Aneurysm

Intervention

PEVAR (ProGlide closure)

Study Arms / Comparison Groups

 Standard EVAR (IntuiTrak)

Description:  EVAR using standard vascular exposure for access

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

150

Start Date

April 2010

Completion Date

January 2014

Primary Completion Date

January 2013

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 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01070069

Organization ID

CP-0001

Responsible Party

Sponsor

Study Sponsor

Endologix

Collaborators

 Abbott Medical Devices

Study Sponsor

, , 

Verification Date

January 2014