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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tunis, Tunisia, 1008
- Recruiting
- Military Hospital of Tunis
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Contact:
- Stambouli Nejla
- Phone Number: 0021655104234
- Email: nejlastam@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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
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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:
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Active Comparator: conventional radial artery approach
Elective percutaneous coronary intervention through conventional radial artery access
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Puncture success rate
Time Frame: During the procedure
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Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)
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During the procedure
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Radial artery occlusion rate
Time Frame: 30 days
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Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Crossover rate
Time Frame: During the procedure
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Comparison of the access site crossover rate in each group to complete the staged procedure
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During the procedure
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Duration of the puncture
Time Frame: During the procedure
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Exact measurement of puncture duration in seconds
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During the procedure
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Radial artery spasm
Time Frame: During the procedure
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The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered
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During the procedure
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Number of patients presenting hematoma
Time Frame: 24 hours
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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).
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24 hours
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Pain scale
Time Frame: 24 hours
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through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable
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24 hours
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QuickDASH questionnaire
Time Frame: 30 days
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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)
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30 days
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Operator satisfaction
Time Frame: at the end of the inclusion
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through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied
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at the end of the inclusion
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- santemilitaire7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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