Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial

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Published Mar 13, 2022
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Vol. 100 No. 3 (2022): Issue Mar 2022

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Ahmed Ben Amara
Aymen Noamen
Yassine Anouar
Sarra Chenik
Nadhem Hajlaoui
Wafa Fehri

Abstract

Research Problem : The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is
effective and 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.

Investigative process : This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional
radial approach. Two hundred 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 occlusion rate of the punctured radial artery
attributed to the end of hemostasis and to 30 days.

Secondary endpoints : catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH
pain score, Operator satisfaction. A single blind analysis will be led according to the per-protocol and intention-to-treat methods.

Research Plan : Ethical considerations will be undertaken and respected. This trial will run for four months from February 2022. The results
will provide parameters related to the efficacy and safety of the distal radial approach, improving clinical practice.

Trial registration : NCT05311111

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