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

University Health Network, Toronto

Status and phase: Unknown; Phase 1

Conditions: Abdominal Aortic Aneurysm (AAA)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02295137

UHN

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

pre-procedure image guidance

Experimental group

Treatment:

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