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Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

2014-08-27 03:15:50 | BioPortfolio

Summary

To determine the safety and effectiveness of PEVAR.

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Abdominal Aortic Aneurysm

Intervention

PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)

Location

Loma Linda VA Medical Center
Loma Linda
California
United States
92357

Status

Enrolling by invitation

Source

Endologix

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:50-0400

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PubMed Articles [681 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

The tendency to perceive an incomplete pattern or object as complete or whole. This includes the Gestalt Law of Closure.

Therapeutic closure of spaces caused by the extraction of teeth, the congenital absence of teeth, or the excessive space between teeth.

Heart murmurs which are systolic in timing. They occur between the first and the second HEART SOUNDS, between the closure of MITRAL VALVE and TRICUSPID VALVE and the closure of semilunar aortic and pulmonary valves. Systolic murmurs include ejection murmurs and regurgitant murmurs.

Congenital malformations of the central nervous system and adjacent structures related to defective neural tube closure during the first trimester of pregnancy generally occurring between days 18-29 of gestation. Ectodermal and mesodermal malformations (mainly involving the skull and vertebrae) may occur as a result of defects of neural tube closure. (From Joynt, Clinical Neurology, 1992, Ch55, pp31-41)

Premature closure of one or more sutures of the skull.

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