Efficacy and Safety of the Distal Radial Approach

NCT05311111 | Unknown

• 1 other identifier: santemilitaire7
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Complication; Coronary Artery Disease

Keywords

Radial artery; coronary angiography; percutaneous coronary intervention; safety; efficacy; radial approach; anatomical snuff box

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Crossover rate

  During the procedure

• Duration of the puncture

  During the procedure

• Radial artery spasm

  During the procedure

• Number of patients presenting hematoma

  24 hours

• Pain scale

  24 hours

Study Arms (2)

distal radial artery approach

EXPERIMENTAL

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

conventional radial artery approach

ACTIVE COMPARATOR

Elective percutaneous coronary intervention through conventional radial artery access

Procedure: conventional radial artery approach

Interventions

distal radial artery approach PROCEDURE

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.

Also known as: DRA

distal radial artery approach

conventional radial artery approach PROCEDURE

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.

Also known as: TRA

conventional radial artery approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Administration of Military Health, Tunisia: lead

Study Sites (1)

Military hospital of Tunis

Tunis, 1008, Tunisia

RECRUITING

Related Publications (1)

• 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.

  PMID: 36005910 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Aymen Noamen, MD

  military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

  PRINCIPAL INVESTIGATOR

• Nadhem Hajlaoui, Pr

  military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

  STUDY DIRECTOR

• Wafa Fehri, Pr

  military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

  STUDY CHAIR

Central Study Contacts

Aymen Noamen, MD

CONTACT

0021620215773; no.aymen@gmail.com

Ahmed Ben Amara, fellow

CONTACT

0021654430166; ahmedbenikhalled@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blind during the analyze
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-blind, randomized controlled trial

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 5, 2022
• Study Start: February 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)