Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

This study has been completed.
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01070069
First received: February 16, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

To determine the safety and effectiveness of PEVAR.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Endologix:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All serious and non-serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stent graft patency and integrity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Health-related Quality of Life Survey [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinical utility measures [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2010
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070069

Locations
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
Mercy Hospital
Chicago, Illinois, United States, 60616
Northwestern University
Chicago, Illinois, United States, 60611
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
Endologix
Abbott Vascular
  More Information

No publications provided by Endologix

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT01070069     History of Changes
Other Study ID Numbers: CP-0001
Study First Received: February 16, 2010
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Endologix:
Percutaneous
Preclose
Endologix
Abbott Vascular
Endovascular
PEVAR
Stent graft
Suture mediated closure devices

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

ClinicalTrials.gov processed this record on September 30, 2014