Transradial Selective Catheterization of the Celiac Artery in Obese Patients
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|ClinicalTrials.gov Identifier: NCT03434665|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 22, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: Transradial celiac artery angiography||Not Applicable|
- A significant proportion of patients referred to IUCPQ-UL catheterization laboratory are overweight (body mass index >25 kg/m²).
- Ongoing research and early clinical experience suggest that embolization of the left gastric artery could drastically reduce ghrelin levels and be associated with significant weight loss.
- In obese patients, catheterization using femoral artery access is associated with higher risks of vascular complications and peri-procedural bleeding compared to a radial artery approach.
- Given the anatomy (angle) of the celiac artery, selective catheterization of the celiac and left gastric arteries remains challenging, especially in obese patients.
- Before studying the effects of bariatric embolization, more data regarding the access of the left gastric artery is necessary.
- Transradial angiography of the celiac artery/left gastric artery is feasible and safe.
- Given the angulation of celiac artery, catheterization through a radial approach could be simpler.
- Selective angiography of the celiac artery and the left gastric artery can be performed in the setting of uncomplicated coronary angiography/percutaneous coronary intervention (PCI).
- Detailed anatomy of the celiac artery and its branches can be visualized by selective transradial angiography.
- The primary objective is to demonstrate the feasibility and safety of performing selective angiography of the celiac artery using a transradial approach in obese patients referred for diagnostic coronary angiography and/or PCI.
- The secondary objective is to observe anatomical variations of the celiac artery and the left gastric artery.
➢ A prospective pilot study performed at Quebec Heart & Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval; IUCPQ-UL).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Feasibility pilot study|
|Masking:||None (Open Label)|
|Official Title:||Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Transradial celiac artery angiography
Procedure: Transradial celiac artery angiography
- Percentage of successful selective angiographies [ Time Frame: Baseline ]The primary end-point will be the percentage of successful selective angiographies of the celiac artery.
- Incidence of complications of angiographies [ Time Frame: Baseline ]As catheterization and angiography of the celiac artery is an endovascular procedure, the incidence of vessel trauma (such as dissection or perforation) during the procedure will be assessed. All cine films will be reviewed by a multidisciplinary team.
- Procedure duration [ Time Frame: Baseline ]Time (minutes) required to complete the angiography of the celiac artery
- Contrast volume [ Time Frame: Baseline ]Volume (mL) of contrast required to complete the angiography of the celiac artery
- Radiation exposure (duration) [ Time Frame: Baseline ]Fluoroscopy time (minutes) required to complete the angiography of the celiac artery
- Radiation exposure (dose) [ Time Frame: Baseline ]Dose area product (Gy·cm2) required to complete the angiography of the celiac artery
- Number of catheters [ Time Frame: Baseline ]The number of catheters required to complete the angiography of the celiac artery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434665
|Contact: Olivier F Bertrand, MD PhD||+1 418 656 firstname.lastname@example.org|
|Contact: Charles Pirlet, MD||+1 418 656 email@example.com|
|Quebec Heart & Lung Institute (IUCPQ-UL)||Recruiting|
|Quebec City, Quebec, Canada, G1V 4G5|
|Contact: Olivier F Bertrand, MD PhD +1 418 656 8711|
|Contact: Charles Pirlet, MD +1 418 656 8711|
|Principal Investigator: Olivier F Bertrand, MD PhD|
|Principal Investigator:||Olivier F Bertrand, MD PhD||IUCPQ-UL and Laval University|