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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

February 16, 2010
January 27, 2014
April 2010
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01070069 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
  • Device: PEVAR (ProGlide closure)
    Percutaneous EVAR facilitated by the ProGlide closure device
    Other Names:
    • IntuiTrak
    • ProGlide
  • Device: SEVAR (IntuiTrak)
    Standard vascular exposure for access prior to EVAR
    Other Name: IntuiTrak
  • Device: PEVAR (Prostar XL closure)
    Percutaneous EVAR facilitated by the Prostar XL closure device
    Other Names:
    • IntuiTrak
    • Prostar XL
  • Active Comparator: Standard EVAR (IntuiTrak)
    EVAR using standard vascular exposure for access
    Intervention: Device: SEVAR (IntuiTrak)
  • Experimental: PEVAR (ProGlide closure)
    Percutaneous EVAR facilitated by the ProGlide closure device
    Intervention: Device: PEVAR (ProGlide closure)
  • Experimental: PEVAR (ProstarXL closure)
    Percutaneous EVAR facilitated by the Prostar XL closure device
    Intervention: Device: PEVAR (Prostar XL closure)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070069
CP-0001
Yes
Endologix
Endologix
Abbott Vascular
Not Provided
Endologix
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP