Status:
UNKNOWN
Efficacy and Safety of the Distal Radial Approach
Lead Sponsor:
General Administration of Military Health, Tunisia
Conditions:
Vascular Access Complication
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this non-inferiority trial is to determine if the distal radial access (DRA) during percutaneous coronary intervention (PCI) has an acceptable efficacy compared to the reference access thro...
Detailed Description
The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective, feasible, but associated with a risk of occlusion of the radial artery. T...
Eligibility Criteria
Inclusion
- Over 18 years old.
- Hospitalized in the cardiology department of the military hospital of Tunis.
- elective Percutaneous coronary intervention performed by experienced operators or fellows trained in the proximal and distal radial approach
- Non-inclusion criteria:
- not provided written informed consent
- both radial arteries were used for prior catheterization
- Under oral anticoagulation
- Having coronary bypass surgery
- Hemodynamic instability
- contra-indication to the radial approach:
- Orthopedic surgery: amputation
- Severe burns of both upper limbs.
- Radial artery pulse not palpable, negative modified Allen test or Barbeau classification type D
- Identified radial vascular anomaly: stenosis, fistula, tortuosity not allowing passage of the catheter
Exclusion
- death within a short period of time after admission
- PCI by the same puncture site will be performed within 30 days after the first puncture
- lost to follow-up
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05311111
Start Date
February 1 2022
End Date
June 30 2022
Last Update
April 11 2022
Active Locations (1)
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1
Military hospital of Tunis
Tunis, Tunisia, 1008