Endovascular Aneurysm Repair (EVAR) Gate Study

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Endovascular Aneurysm Repair (EVAR) Gate Study

Official Title

Evaluation of a Randomized Comparison of Direct Versus Snare Techniques for Cannulation of Contralateral Gate During an Endovascular Aneurysm Repair (EVAR) Procedure

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.

Detailed Description

      Endografts currently FDA-approved for abdominal aortic aneurysm (AAA) repair are modular
      systems,comprised 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 limb.Cannulation 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 Type

Interventional

Primary Outcome

Primary Endpoint: Time to contralateral gate cannulation

Condition

Abdominal Aortic Aneurysm (AAA)

Intervention

Endovascular Aneurysm Repair

Study Arms / Comparison Groups

 Retrograde Gate Cannulation
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

102

Start Date

August 2011

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jessica Titus, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02934087

Organization ID

EV001

Responsible Party

Sponsor

Study Sponsor

Minneapolis Heart Institute Foundation

Study Sponsor

Jessica Titus, MD, Principal Investigator, Minneapolis Heart Institute Foundation

Verification Date

October 2016