COROTAB: Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05725616
Collaborator
(none)
326
2
13

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Coronary angiography
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
326 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography: Comparative Non-inferiority Study With the Radial Arterial Approach to the Wrist
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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

Procedure: 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

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

Outcome Measures

Primary Outcome Measures

  1. Success rate of coronary angiography without changing puncture route. [1 day]

    The primary endpoint is the success rate of coronary angiography without changing puncture route.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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....

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05725616
Other Study ID Numbers:
  • 2022-A01928-35
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 13, 2023