Efficacy and Safety of the Distal Radial Approach

Coronary Artery Disease Clinical Trial

— TunDRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311111
• Other study ID #: santemilitaire7
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2022
• Source: General Administration of Military Health, Tunisia
• Contact: Aymen Noamen, MD
• Phone: 0021620215773
• Email: no.aymen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Vascular Access Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	Military hospital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
General Administration of Military Health, Tunisia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puncture success rate	Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)	During the procedure
Primary	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	Crossover rate	Comparison of the access site crossover rate in each group to complete the staged procedure	During the procedure
Secondary	Duration of the puncture	Exact measurement of puncture duration in seconds	During the procedure
Secondary	Radial artery spasm	The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered	During the procedure
Secondary	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
Secondary	Pain scale	through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable	24 hours
Secondary	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
Secondary	Operator satisfaction	through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied	at the end of the inclusion