- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05725616
Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography (COROTAB)
Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography: Comparative Non-inferiority Study With the Radial Arterial Approach to the Wrist
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Coronary angiography is the reference examination for anatomical exploration coronary arteries to determine the presence or absence of a predominantly obstructive coronary disease.
Historically, the femoral approach was the most common approach used in interventional cardiology. The radial approach to the forearm presents multiple advantages over the femoral route, and it became the gold standard approach to coronary angiography and intervention percutaneous coronary. Although uncommon, vascular complications related to the radial pathway exist.
This is why a more distal radial approach, above the long tendon extensor of the thumb (at the level of the anatomical snuff box) or downstream (at the back of the hand) was suggested more than 10 years ago. This pathway is now an advantageous alternative to the radial approach of first intention, both for the patient and for the practitioner.
The two procedures are common today but few studies have been developed to compare the two approaches. Therefore, the main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Villeurbanne, France, 69100
- Cardiologie Tonkin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient, male or female, aged 18 and over
- Patient having a diagnostic coronary angiography programmed by radial route.
- Patient with a radial pulse at the anatomical snuff box and at the wrist noticeable
Exclusion Criteria:
- Patient requiring emergency coronary angiography or having an acute coronary syndrome
- Patient with severe arteriopathy of the supra-aortic trunks
- Patient with a history of coronary bypass surgery
- Tall patients (>1.90m)
- Patient allergic to xylocaine
- Patient presenting a contraindication to the realization of a coronary angiography:
terminal IRC, pregnancy, severe sepsis....
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Snuff box puncture
Puncture of the radial artery at of the anatomical snuff box or on the back of the hand during coronary angiography
|
Snuff Box Approach or radial Arterial Approach at wrist for coronary angiography.
|
|
Active Comparator: Wrist puncture
Puncture of the radial artery at the level of the base of the wrist during coronary angiography
|
Snuff Box Approach or radial Arterial Approach at wrist for coronary angiography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate of coronary angiography without changing puncture route.
Time Frame: 1 day
|
The primary endpoint is the success rate of coronary angiography without changing puncture route.
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-A01928-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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