Clinical trial NCT05311111: Efficacy and Safety of the Distal Radial Approach
Official title: Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Complication
Coronary Artery Disease
Keywords: Radial artery
coronary angiography
percutaneous coronary intervention
safety
efficacy
radial approach
anatomical snuff box
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2022-04-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, single-blind, randomized controlled trial
Primary purpose: PREVENTION

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.

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:

  * 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 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

Primary outcomes:
measure: Puncture success rate
timeFrame: During the procedure
measure: Radial artery occlusion rate
timeFrame: 30 days
Secondary outcomes:
measure: Crossover rate
timeFrame: During the procedure
measure: Duration of the puncture
timeFrame: During the procedure
measure: Radial artery spasm
timeFrame: During the procedure
measure: Number of patients presenting hematoma
timeFrame: 24 hours
measure: Pain scale
timeFrame: 24 hours
measure: QuickDASH questionnaire
timeFrame: 30 days
measure: Operator satisfaction
timeFrame: at the end of the inclusion
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military hospital of Tunis
Study officials:
affiliation: military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
name: Aymen Noamen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
name: Nadhem Hajlaoui, Pr
role: STUDY_DIRECTOR
affiliation: military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
name: Wafa Fehri, Pr
role: STUDY_CHAIR
References:
citation: Ben Amara A, Noamen A, Anouar Y, Chenik S, Hajlaoui N, Fehri W. Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial. Tunis Med. 2022 mars;100(3):192-202.