Ignite Creation Date:
2024-05-05 @ 10:17 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01070069
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2010-02-16
Brief Title:
Percutaneous Endovascular Aneurysm Repair PEVAR Trial
Sponsor:
Endologix
Organization:
Endologix
Study Overview
Official Title:
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
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEVAR
Brief 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 inclusionexclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 21 Physicians who are established experts in the field of percutaneous EVAR will participate in the trial
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 inclusionexclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 21 Physicians who are established experts in the field of percutaneous EVAR will participate in the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None