Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography

Coronary Angiography Clinical Trial

— COROTAB  

Official title:

Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography: Comparative Non-inferiority Study With the Radial Arterial Approach to the Wrist

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725616
• Other study ID #: 2022-A01928-35
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Patrick STAAT, MD
• Phone: + 33 6 77 34 49 69
• Email: staatpatrick[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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....

Related Conditions & MeSH terms

• Coronary Angiography

Intervention

Procedure:
• Coronary angiography
Snuff Box Approach or radial Arterial Approach at wrist for coronary angiography.

Locations

Country	Name	City	State
France	Cardiologie Tonkin	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of coronary angiography without changing puncture route.	The primary endpoint is the success rate of coronary angiography without changing puncture route.	1 day