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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02295137
Other study ID # UHN
Secondary ID
Status Recruiting
Phase Phase 1
First received October 27, 2014
Last updated November 14, 2014
Start date February 2014
Est. completion date October 2015

Study information

Verified date October 2014
Source University Health Network, Toronto
Contact Kong Teng Tan, MD
Phone 416-340-4800
Email kongteng.tan@uhn.ca
Is FDA regulated No
Health authority Canada: Ministry of Health & Long Term Care, Ontario
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- male or female >= 18 years;

- scheduled for advanced EVAR for abdominal aortic aneurysm.

Exclusion Criteria:

- Pregnancy;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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


Locations

Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure success Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance within 1 day No
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