Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Access Complication
- Sponsor
- General Administration of Military Health, Tunisia
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Puncture success rate
- Last Updated
- 4 years ago
Overview
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 through the conventional radial artery (TRA) with a lower rate of radial artery occlusion (RAO) in real life practice.
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. The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients. This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach. This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the rate of 30-day occlusion of the punctured radial artery. Secondary endpoints: catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH score, pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods. Avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas. The results will provide the parameters related to the efficacy and safety of the distal radial approach, so improving clinical practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Puncture success rate
Time Frame: During the procedure
Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)
Radial artery occlusion rate
Time Frame: 30 days
Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized.
Secondary Outcomes
- Crossover rate(During the procedure)
- Radial artery spasm(During the procedure)
- Duration of the puncture(During the procedure)
- QuickDASH questionnaire(30 days)
- Number of patients presenting hematoma(24 hours)
- Pain scale(24 hours)
- Operator satisfaction(at the end of the inclusion)