Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02934087
Status:
COMPLETED
Last Update Posted:
2016-10-14
First Post:
2011-08-05
Brief Title:
Endovascular Aneurysm Repair EVAR Gate Study
Sponsor:
Minneapolis Heart Institute Foundation
Organization:
Minneapolis Heart Institute Foundation
Study Overview
Official Title:
Evaluation of a Randomized Comparison of Direct Versus Snare Techniques for Cannulation of Contralateral Gate During an Endovascular Aneurysm Repair EVAR Procedure
Status:
COMPLETED
Status Verified Date:
2016-10
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:
EVAR
Brief Summary:
This study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair EVAR procedure
This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure
This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure
Detailed Description:
Endografts currently FDA-approved for abdominal aortic aneurysm AAA repair are modular systemscomprised of a main body Aortic Trunk and two legs Ipsilateral Leg Endoprosthesis and a contralateral leg endoprosthesis In placement of the endograft the main body and ipsilateral limb are deployed from a retrograde common femoral artery approach From the contralateral femoral artery cannulation of the contralateral gate is required to deploy the contralateral iliac limbCannulation of the contralateral limb gate is the portion of the operation that requires the most wire skills Depending on the patients body type angulations of the aorta and the size and volume of the AAA this portion of the procedure can be technically difficult This portion may become lengthy and discouraging if the surgeon fails to cannulate the gate using a particular approach Cannulation of the contralateral limb gate from a retrograde femoral artery approach is commonly achieved by first using a maneuverable guidewire and steerable catheter Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft which can be accomplished with a curved catheter The wire may be retrieved on the contralateral limb using a snare device The problem and why it is important -- difficulty in accessing the contralateral gate leads to increase procedural time and excess exposure to radiation The standard of care is retrograde cannulation with the use of crossover snare techniques as a secondary adjunct if retrograde cannulation fails In this study we will compare retrograde cannulation to primary snaring
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