Transradial Selective Catheterization of the Celiac Artery in Obese Patients

NCT03434665 | Completed

• 1 other identifier: EASY-AngioBar
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Angiography; Bariatric embolization; Gastric artery; Obesity; Transradial

Outcome Measures

Primary Outcomes (1)

• Percentage of successful selective angiographies

  The primary end-point will be the percentage of successful selective angiographies of the celiac artery.

  Baseline

Secondary Outcomes (6)

• Incidence of complications of angiographies

  Baseline

• Procedure duration

  Baseline

• Contrast volume

  Baseline

• Radiation exposure (duration)

  Baseline

• Radiation exposure (dose)

  Baseline

Study Arms (1)

Recruited patients

OTHER

Transradial celiac artery angiography

Procedure: Transradial celiac artery angiography

Interventions

Transradial celiac artery angiography PROCEDURE

* 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.

Recruited patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coronary angiography with a BMI \>30 kg/m² will be eligible.

You may not qualify if:

• Kidney disease defined by a glomerular filtration rate less than 60 ml/min/m² according to the Modification of Diet in Renal Disease (MDRD) formula;
• Previous gastric or bariatric surgery;
• Emergency coronary procedure.
• Furthermore, the procedure will be cancelled if one of the following criteria are met during the coronary angiography:
• Contrast volume \>250 ml;
• Radiation dose \>180 Gy.cm² as assessed by the dose area product (DAP).

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Quebec Heart & Lung Institute (IUCPQ-UL)

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier F Bertrand, MD PhD

  IUCPQ-UL and Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD; Interventional Cardiologist, Quebec Heart-Lung Institute; Associate-Professor, Faculty of Medicine, Laval University

Model Details: Feasibility pilot study

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 15, 2018
• Study Start: February 9, 2018
• Primary Completion: May 31, 2019
• Study Completion: September 30, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

CA (1)