UnknownPhase 1

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

Canada20 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male or female \>= 18 years; * scheduled for advanced EVAR for abdominal aortic aneurysm. Exclusion Criteria: * Pregnancy;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedure success

Timeframe: within 1 day

Trial details

NCT IDNCT02295137

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

Contact for this trial

Kong Teng Tan, MD

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

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm (AAA) trials