Transradial Selective Catheterization of the Celiac Artery in Obese Patients
NCT03434665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2019-11-26
Summary
BACKGROUND:
* Obesity, with its associated comorbidities, is set to become a major risk factor for cardiovascular disease in the 21st century. To this day, diet and medical therapy have proven only limited efficacy and bariatric surgery remains the last resort for many severely obese patients who wish to lose weight, modify their cardiovascular risk factors and ultimately modify their long-term prognosis. However, bariatric surgery remains associated with significant procedural morbidity and many patients are not eligible for such a surgery procedure as the risk-benefit ratio of bariatric surgery in severe obese patients with coronary artery disease is not yet well known.
* Recently, percutaneous left gastric artery embolization has been reported as a promising technique leading to a body weight loss that is equivalent to bariatric surgery.
* In the context of an endovascular procedure in obese patients, vascular access is a major concern. Transradial access (or radial artery approach) has been consistently associated with significant reductions in access-site related vascular complications and peri-procedural bleeding compared to the standard transfemoral access (or femoral artery approach). This is particularly evident in patients with severe obesity.
* Visceral arteries most often have an acute angulation with the aorta which makes them more easily cannulated from above (transradial access) compared to below (transfemoral access). Preliminary experience has shown that cannulation of the celiac artery is feasible from transfemoral and transradial access, the latter being associated with shorter procedural time and less contrast agent use. To date, several pilot studies have reported successful percutaneous embolization of the left gastric artery with biodegradable microspheres. This appears to be a promising technique to reduce weight in severely obese patients.
* Prior to launching a randomized trial, further study is warranted regarding the feasibility and safety aspects of transradial angiography of the celiac artery.
Conditions
Interventions
- PROCEDURE
-
Transradial celiac artery angiography
* After completion of transradial diagnostic coronary angiography and/or PCI, before removal of the radial arterial sheath, selective angiography of the celiac artery will be performed. * Technically, a 0.35-inch wire is advanced into the descending aorta. A 125 cm 5-French Judkins right catheter is inserted over this wire, which is then removed. The distal tip of the catheter is brought in front of the ostium of the celiac artery and positioning is confirmed with angiography of the celiac artery. Two or three views will be obtained to determine the optimal view to visualize the left gastric artery anatomy. All material is removed and hemostasis is obtained as per clinical routine for coronary angiography.
Sponsors & Collaborators
-
Laval University
lead OTHER
Principal Investigators
-
Olivier F Bertrand, MD PhD · IUCPQ-UL and Laval University
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-09
- Primary Completion
- 2019-05-31
- Completion
- 2019-09-30
Countries
- Canada
Study Locations
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