Efficacy and Safety of the Distal Radial Approach (TunDRA)

General Administration of Military Health, Tunisia

Status: Unknown

Conditions: Coronary Artery Disease; Vascular Access Complication

Treatments: Procedure: conventional radial artery approach; Procedure: distal radial artery approach

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05311111

santemilitaire7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

distal radial artery approach

Experimental group

Description:

Elective percutaneous coronary intervention by forearm radial artery through the distal radial artery in the dorsum of the hand or the anatomical snuff-box

Treatment:

Procedure: distal radial artery approach

conventional radial artery approach

Active Comparator group

Description:

Elective percutaneous coronary intervention through conventional radial artery access

Treatment:

Procedure: conventional radial artery approach