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

NCT ID: NCT02295137

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm (AAA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pre-procedure image guidance

Group Type EXPERIMENTAL

Using pre-procedural CTA to guide advanced EVAR procedure

Intervention Type PROCEDURE

Interventions

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Using pre-procedural CTA to guide advanced EVAR procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kong Teng Tan, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kong Teng Tan, MD

Role: CONTACT

[email protected]
416-340-4800 ext. 6166

Facility Contacts

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Kong Teng Tan, MD

Role: primary

[email protected]
416-340-4800 ext. 6166

Other Identifiers

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UHN

Identifier Type: -

Identifier Source: org_study_id