- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934087
Endovascular Aneurysm Repair (EVAR) Gate Study (EVAR)
Evaluation of a Randomized Comparison of Direct Versus Snare Techniques for Cannulation of Contralateral Gate During an Endovascular Aneurysm Repair (EVAR) Procedure
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Minneapolis Heart Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18
- Patient is undergoing EVAR repair with a commercially available endograft
- Willing to give consent
- Procedure is Elective
Exclusion Criteria:
- Declines to participate
- Unable to provide consent
- Urgent AAA repair
- Participating in another study
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Retrograde Gate Cannulation
All patients undergoing elective EVAR with a standard commercially available stent graft will be randomized after informed consent obtained; gate cannulation method will be attempted for a period of 15 minutes.
If unsuccessful during this time a crossover to the alternative method (snare) will be attempted.
The study will be terminated at 15 minutes in the crossover arm if still unsuccessful.
|
Endovascular aneurysm repair (or endovascular aortic repair) (EVAR) is a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA)
Other Names:
|
Active Comparator: Snare Technique
All patients undergoing elective EVAR with a standard commercially available stent graft were randomized after informed consent obtained; gate cannulation method was attempted for a period of 15 minutes. If unsuccessful during this time a crossover to the alternative method (retrograde gate cannulation) was attempted. The study will be terminated at 15 minutes in the crossover arm if still unsuccessful. 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. |
Endovascular aneurysm repair (or endovascular aortic repair) (EVAR) is a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint: Time to contralateral gate cannulation
Time Frame: Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .
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The patient will be randomized to either a snare or retrograde technique in a 1:1 ratio intraoperatively at the time of deployment of the main body of the graft.
The timer will be started at 0 when positioning catheter is withdrawn from para-renal position into sac.
The timer will be stopped after successful gate cannulation or after 30 minutes of fluoroscopy time.
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Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .
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Collaborators and Investigators
Investigators
- Principal Investigator: Jessica Titus, MD, Minneapolis Heart Institute Foundation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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