Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
Status
Conditions
Treatments
Details and patient eligibility
About
To determine the safety and effectiveness of PEVAR.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
192 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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