Efficacy and Safety of the Distal Radial Approach (TunDRA)

Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Vascular Access Complication
• Intervention / Treatment: Procedure: distal radial artery approach; Procedure: conventional radial artery approach

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1008
    • Recruiting
    • Military Hospital of Tunis
    • Contact: Stambouli Nejla; Phone Number: 0021655104234; Email: nejlastam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: distal radial artery approach; 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.; Other Names: DRA
Active Comparator: conventional radial artery approach; Elective percutaneous coronary intervention through conventional radial artery access	Procedure: conventional radial artery approach; 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.; Other Names: TRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture success rate	Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)	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.	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Administration of Military Health, Tunisia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 27, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: safety; percutaneous coronary intervention; efficacy; coronary angiography; Radial artery; radial approach; anatomical snuff box
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: santemilitaire7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No