TunDRA: Efficacy and Safety of the Distal Radial Approach

Sponsor
General Administration of Military Health, Tunisia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05311111
Collaborator
(none)
250
1
2
4.9
51.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: distal radial artery approach
  • Procedure: conventional radial artery approach
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, single-center, single-blind, randomized controlled trialProspective, single-center, single-blind, randomized controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
single blind during the analyze
Primary Purpose:
Prevention
Official Title:
Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Puncture success rate [During the procedure]

      Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)

    2. 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

    1. Crossover rate [During the procedure]

      Comparison of the access site crossover rate in each group to complete the staged procedure

    2. Duration of the puncture [During the procedure]

      Exact measurement of puncture duration in seconds

    3. Radial artery spasm [During the procedure]

      The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered

    4. 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).

    5. Pain scale [24 hours]

      through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable

    6. 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)

    7. Operator satisfaction [at the end of the inclusion]

      through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Military hospital of Tunis Tunis Tunisia 1008

    Sponsors and Collaborators

    • General Administration of Military Health, Tunisia

    Investigators

    • Principal Investigator: Aymen Noamen, MD, military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
    • Study Director: Nadhem Hajlaoui, Pr, military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
    • Study Chair: Wafa Fehri, Pr, military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Administration of Military Health, Tunisia
    ClinicalTrials.gov Identifier:
    NCT05311111
    Other Study ID Numbers:
    • santemilitaire7
    First Posted:
    Apr 5, 2022
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by General Administration of Military Health, Tunisia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2022