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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
Sponsor:
Information provided by (Responsible Party):
Olivier F. Bertrand, Laval University

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Transradial celiac artery angiography Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility pilot study
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Recruited patients
Transradial celiac artery angiography
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.




Primary Outcome Measures :
  1. Percentage of successful selective angiographies [ Time Frame: Baseline ]
    The primary end-point will be the percentage of successful selective angiographies of the celiac artery.


Secondary Outcome Measures :
  1. 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.

  2. Procedure duration [ Time Frame: Baseline ]
    Time (minutes) required to complete the angiography of the celiac artery

  3. Contrast volume [ Time Frame: Baseline ]
    Volume (mL) of contrast required to complete the angiography of the celiac artery

  4. Radiation exposure (duration) [ Time Frame: Baseline ]
    Fluoroscopy time (minutes) required to complete the angiography of the celiac artery

  5. Radiation exposure (dose) [ Time Frame: Baseline ]
    Dose area product (Gy·cm2) required to complete the angiography of the celiac artery

  6. Number of catheters [ Time Frame: Baseline ]
    The number of catheters required to complete the angiography of the celiac artery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
Contact: Olivier F Bertrand, MD PhD +1 418 656 8711 olivier.bertrand@crhl.ulaval.ca
Contact: Charles Pirlet, MD +1 418 656 8711 charles-antoine-eugene.pirlet.1@ulaval.ca

Locations
Canada, Quebec
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         
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Olivier F Bertrand, MD PhD IUCPQ-UL and Laval University

Responsible Party: Olivier F. Bertrand, MD PhD; Interventional Cardiologist, Quebec Heart-Lung Institute; Associate-Professor, Faculty of Medicine, Laval University, Laval University
ClinicalTrials.gov Identifier: NCT03434665     History of Changes
Other Study ID Numbers: EASY-AngioBar
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be completed

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Olivier F. Bertrand, Laval University:
Angiography
Bariatric embolization
Gastric artery
Obesity
Transradial