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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05725616
Other study ID # 2022-A01928-35
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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....

Study Design


Related Conditions & MeSH terms


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
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