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

NCT02295137 | Unknown Phase 1

• 1 other identifier: UHN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Outcome Measures

Primary Outcomes (1)

• Procedure success

  Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance

  within 1 day

Study Arms (1)

pre-procedure image guidance

EXPERIMENTAL

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

Interventions

Using pre-procedural CTA to guide advanced EVAR procedure PROCEDURE

pre-procedure image guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy;

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1C4, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Kong Teng Tan, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kong Teng Tan, MD

CONTACT

416-340-4800; kongteng.tan@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 20, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 20, 2014

Record last verified: 2014-10

Locations

CA (1)