Transradial Selective Catheterization of the Celiac Artery in Obese Patients
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transradial celiac artery angiography
Sponsored by

About this trial
This is an interventional other trial for Obesity focused on measuring Angiography, Bariatric embolization, Gastric artery, Obesity, Transradial
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing coronary angiography with a BMI >30 kg/m² will be eligible.
Exclusion Criteria:
- 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).
Sites / Locations
- Quebec Heart & Lung Institute (IUCPQ-UL)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Recruited patients
Arm Description
Transradial celiac artery angiography
Outcomes
Primary Outcome Measures
Percentage of successful selective angiographies
The primary end-point will be the percentage of successful selective angiographies of the celiac artery.
Secondary Outcome Measures
Incidence of complications of angiographies
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 (minutes) required to complete the angiography of the celiac artery
Contrast volume
Volume (mL) of contrast required to complete the angiography of the celiac artery
Radiation exposure (duration)
Fluoroscopy time (minutes) required to complete the angiography of the celiac artery
Radiation exposure (dose)
Dose area product (Gy·cm2) required to complete the angiography of the celiac artery
Number of catheters
The number of catheters required to complete the angiography of the celiac artery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03434665
Brief Title
Transradial Selective Catheterization of the Celiac Artery in Obese Patients
Official Title
Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
RATIONALE:
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.
HYPOTHESES:
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.
OBJECTIVES:
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.
STUDY DESIGN:
> A prospective pilot study performed at Quebec Heart & Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval; IUCPQ-UL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Angiography, Bariatric embolization, Gastric artery, Obesity, Transradial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recruited patients
Arm Type
Other
Arm Description
Transradial celiac artery angiography
Intervention Type
Procedure
Intervention Name(s)
Transradial celiac artery angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of successful selective angiographies
Description
The primary end-point will be the percentage of successful selective angiographies of the celiac artery.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Incidence of complications of angiographies
Description
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.
Time Frame
Baseline
Title
Procedure duration
Description
Time (minutes) required to complete the angiography of the celiac artery
Time Frame
Baseline
Title
Contrast volume
Description
Volume (mL) of contrast required to complete the angiography of the celiac artery
Time Frame
Baseline
Title
Radiation exposure (duration)
Description
Fluoroscopy time (minutes) required to complete the angiography of the celiac artery
Time Frame
Baseline
Title
Radiation exposure (dose)
Description
Dose area product (Gy·cm2) required to complete the angiography of the celiac artery
Time Frame
Baseline
Title
Number of catheters
Description
The number of catheters required to complete the angiography of the celiac artery
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing coronary angiography with a BMI >30 kg/m² will be eligible.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier F Bertrand, MD PhD
Organizational Affiliation
IUCPQ-UL and Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quebec Heart & Lung Institute (IUCPQ-UL)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be completed
Learn more about this trial
Transradial Selective Catheterization of the Celiac Artery in Obese Patients
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