Endovascular Aneurysm Repair (EVAR) Gate Study

NCT02934087 | Completed DMC

• 1 other identifier: EV001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

snare technique; cannulation of contralateral gate; endovascular; aneurysm; AAA; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint: Time to contralateral gate cannulation

  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 The timer will be started at 0 when positioning catheter is withdrawn from para-renal position into sac.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.

  Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .

Study Arms (2)

Retrograde Gate Cannulation

ACTIVE COMPARATOR

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.

Procedure: Endovascular Aneurysm Repair

Snare Technique

ACTIVE COMPARATOR

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.

Procedure: Endovascular Aneurysm Repair

Interventions

Endovascular Aneurysm Repair PROCEDURE

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)

Also known as: EVAR

Retrograde Gate Cannulation; Snare Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Patient is undergoing EVAR repair with a commercially available endograft
• Willing to give consent
• Procedure is Elective

You may not qualify if:

• Declines to participate
• Unable to provide consent
• Urgent AAA repair
• Participating in another study

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (1)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Jessica Titus, MD

  Minneapolis Heart Institute Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: October 14, 2016
• Study Start: August 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)