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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
250
Procedure: Use of radial artery for access for a coronary angiography or intervention After preparation and local anesthesia, the operator will puncture the distal radial artery in the dorsum of the hand or the anatomical snuff-box. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion.
Procedure: conventional radial access for a percutaneous coronary intervention After preparation and local anesthesia, the operator will puncture the proximal radial artery at the conventional site in distal forearm. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion.
Military hospital of Tunis
Tunis, Tunisia
RECRUITINGPuncture success rate
Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)
Time frame: During the procedure
Radial artery occlusion rate
Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized.
Time frame: 30 days
Crossover rate
Comparison of the access site crossover rate in each group to complete the staged procedure
Time frame: During the procedure
Duration of the puncture
Exact measurement of puncture duration in seconds
Time frame: During the procedure
Radial artery spasm
The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered
Time frame: During the procedure
Number of patients presenting hematoma
Hematoma according to Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) score, The score ranges from 1 (≤5 cm diameter) to 5 ( ischemic threat of the hand).
Time frame: 24 hours
Pain scale
through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable
Time frame: 24 hours
QuickDASH questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) score is used to assess hand function. The score ranges from 0 (no disability) to 100 (most severe disability)
Time frame: 30 days
Operator satisfaction
through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied
Time frame: at the end of the inclusion