Efficacy and Safety of the Distal Radial Approach

Not Applicable

• Conditions: Vascular Access Complication; Coronary Artery Disease
• Interventions: Procedure: distal radial artery approach; Procedure: conventional radial artery approach

• Registration Number: NCT05311111
• Lead Sponsor: General Administration of Military Health, Tunisia

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.

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-27
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-05
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
distal radial artery approach	distal radial artery approach	Elective percutaneous coronary intervention by forearm radial artery through the distal radial artery in the dorsum of the hand or the anatomical snuff-box
conventional radial artery approach	conventional radial artery approach	Elective percutaneous coronary intervention through conventional radial artery access

Primary Outcome Measures

Name	Time	Method
Puncture success rate	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	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 Outcome Measures

Name	Time	Method
Crossover rate	During the procedure	Comparison of the access site crossover rate in each group to complete the staged procedure
Radial artery spasm	During the procedure	The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered
Duration of the puncture	During the procedure	Exact measurement of puncture duration in seconds
QuickDASH questionnaire	30 days	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)
Number of patients presenting hematoma	24 hours	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).
Pain scale	24 hours	through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable
Operator satisfaction	at the end of the inclusion	through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied

Trial Locations

Locations (1)

Military hospital of Tunis; 🇹🇳 Tunis, Tunisia