ObesityNCT03434665
Transradial Selective Catheterization of the Celiac Artery in Obese Patients
A study testing Transradial celiac artery angiography in people with Obesity, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Transradial celiac artery angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiography with a BMI >30 kg/m² will be eligible.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study
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.
Read the 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).
- Conditions
- Obesity
- Being tested
- Transradial celiac artery angiography
- Keywords
- Angiography, Bariatric embolization, Gastric artery, Obesity, Transradial
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial celiac artery angiographyProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Recruited patients | Other | Transradial celiac artery angiography Receives: Procedure: Transradial celiac artery angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful selective angiographies
The primary end-point will be the percentage of successful selective angiographies of the celiac artery.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: Baseline
Procedure duration
Time (minutes) required to complete the angiography of the celiac artery
Measured: Baseline
Contrast volume
Volume (mL) of contrast required to complete the angiography of the celiac artery
Measured: Baseline
Radiation exposure (duration)
Fluoroscopy time (minutes) required to complete the angiography of the celiac artery
Measured: Baseline
Radiation exposure (dose)
Dose area product (Gy·cm2) required to complete the angiography of the celiac artery
Measured: Baseline
Number of catheters
The number of catheters required to complete the angiography of the celiac artery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start9 Feb 2018
- Primary completion31 May 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility pilot study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F Bertrand, MD PhD, Principal investigator, IUCPQ-UL and Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434665
- Sponsor's protocol ID
- EASY-AngioBar
- Status last verified
- Nov 2019
- First submitted
- 30 Jan 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be completed
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03434665
- Acronym / sponsor ID
- EASY-AngioBar
- Conditions
- Obesity
- Keywords
- Angiography, Bariatric embolization, Gastric artery, Obesity, Transradial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility pilot study
| Arm | Type | Receives |
|---|---|---|
| Recruited patients | Other | Procedure: Transradial celiac artery angiographyTransradial celiac artery angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing coronary angiography with a BMI >30 kg/m² will be eligible.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Recruited patients |
Primary outcome
Percentage of successful selective angiographies
Time frame: Baseline
The primary end-point will be the percentage of successful selective angiographies of the celiac artery.
6 secondary outcomes
Incidence of complications of angiographies
Time frame: Baseline
Procedure duration
Time frame: Baseline
Contrast volume
Time frame: Baseline
Radiation exposure (duration)
Time frame: Baseline
Radiation exposure (dose)
Time frame: Baseline
Number of catheters
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Undecided. To be completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier F Bertrand, MD PhD principal investigator
IUCPQ-UL and Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transradial celiac artery angiography in people with Obesity, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of successful selective angiographies (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.