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

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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

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

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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Procedure success

Condition

Abdominal Aortic Aneurysm (AAA)

Intervention

Using pre-procedural CTA to guide advanced EVAR procedure

Study Arms / Comparison Groups

 pre-procedure image guidance
Description:

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

20

Start Date

February 2014

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility Criteria

        Inclusion Criteria:

          -  male or female >= 18 years;

          -  scheduled for advanced EVAR for abdominal aortic aneurysm.

        Exclusion Criteria:

          -  Pregnancy;

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kong Teng Tan, MD, 416-340-4800, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT02295137

Organization ID

UHN

Responsible Party

Sponsor

Study Sponsor

University Health Network, Toronto

Study Sponsor

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

Verification Date

October 2014