Endovascular Aneurysm Repair (EVAR) Gate Study

Sponsor

Minneapolis Heart Institute Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT02934087

Collaborator

(none)

102

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm (AAA)	Procedure: Endovascular Aneurysm Repair	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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.	Procedure: Endovascular Aneurysm Repair 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: EVAR
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.	Procedure: Endovascular Aneurysm Repair 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: EVAR

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.

Procedure: Endovascular Aneurysm Repair

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:

EVAR

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.

Procedure: Endovascular Aneurysm Repair

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:

EVAR

Outcome Measures

Primary Outcome Measures

Primary Endpoint: Time to contralateral gate cannulation [Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .]
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.