Recruiting
Phase 1

Image Fusion

Sponsor:

University Health Network, Toronto

Code:

NCT02295137

Conditions

Abdominal Aortic Aneurysm (AAA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Using pre-procedural CTA to guide advanced EVAR procedure

Study Details

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)

Study ID

NCT02295137

Start date

Feb, 2014

Status verified date

Oct, 2014

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy;

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: pre-procedure image guidance

Interventions

Using pre-procedural CTA to guide advanced EVAR procedure

Primary outcome measure

  • Procedure success [ Time Frame: within 1 day ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1C4

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 20, 2014

Last verified

Oct, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2014-11-20.