Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01070069
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Perceptual Closure
The tendency to perceive an incomplete pattern or object as complete or whole. This includes the Gestalt Law of Closure.
Orthodontic Space Closure
Therapeutic closure of spaces caused by the extraction of teeth, the congenital absence of teeth, or the excessive space between teeth.
Systolic Murmurs
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.
Neural Tube Defects
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)
Craniosynostoses
Premature closure of one or more sutures of the skull.
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PubMed Articles
AIM: A totally percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) has been shown in multiple reports to be feasible, but carries attendant risks that appear to increase wit...
PURPOSE: To establish the efficacy and safety of the preclose technique in total percutaneous endovascular aortic repair (PEVAR). METHODS: A systematic literature search of Medline database was conduc...
To retrospectively evaluate the safety and effectiveness of the EXOSEAL vascular closure device (VCD) for first or repeated closure after retrograde percutaneous femoral arterial access.
Percutaneous management of left atrial appendage perforation during device closure.
A 76-year-old male patient was admitted for percutaneous left atrial appendage (LAA) closure because of chronic atrial fibrillation and a history of gastrointestinal bleeding under oral anticoagulatio...
