NCT01070069

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	PEVAR (ProGlide closure)	Percutaneous EVAR facilitated by the ProGlide closure device
DEVICE	SEVAR (IntuiTrak)	Standard vascular exposure for access prior to EVAR
DEVICE	PEVAR (Prostar XL closure)	Percutaneous EVAR facilitated by the Prostar XL closure device

Timeline

• Start date: 2010-04-13
• Primary completion: 2012-03-09
• Completion: 2012-09-05
• First posted: 2010-02-17
• Last updated: 2022-06-07
• Results posted: 2022-06-07

Locations

20 sites across 1 country: United States