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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT02295137

Collaborator

(none)

Enrollment

Location

Arm

19.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm (AAA)	Procedure: Using pre-procedural CTA to guide advanced EVAR procedure	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pre-procedure image guidance	Procedure: Using pre-procedural CTA to guide advanced EVAR procedure

Arm

Intervention/Treatment

Experimental: pre-procedure image guidance

Procedure: Using pre-procedural CTA to guide advanced EVAR procedure

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto General Hospital	Toronto	Ontario	Canada	M5G 1C4

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Kong Teng Tan, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT02295137

Other Study ID Numbers:

First Posted:

Nov 20, 2014

Last Update Posted:

Nov 20, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of Nov 20, 2014