Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair

Phase 1

• Conditions: Abdominal Aortic Aneurysm (AAA)
• Interventions: Procedure: Using pre-procedural CTA to guide advanced EVAR procedure

• Registration Number: NCT02295137
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-10
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• male or female >= 18 years;
• scheduled for advanced EVAR for abdominal aortic aneurysm.

Exclusion Criteria

• Pregnancy;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pre-procedure image guidance	Using pre-procedural CTA to guide advanced EVAR procedure	-

Primary Outcome Measures

Name	Time	Method
Procedure success	within 1 day	Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada