Study Results
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Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2022-02-01
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
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
Elective percutaneous coronary intervention through conventional radial artery access
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* PCI by the same puncture site will be performed within 30 days after the first puncture
* lost to follow-up
18 Years
ALL
No
Sponsors
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General Administration of Military Health, Tunisia
NETWORK
Responsible Party
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Principal Investigators
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Aymen Noamen, MD
Role: PRINCIPAL_INVESTIGATOR
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Nadhem Hajlaoui, Pr
Role: STUDY_DIRECTOR
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Wafa Fehri, Pr
Role: STUDY_CHAIR
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Locations
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Military hospital of Tunis
Tunis, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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santemilitaire7
Identifier Type: -
Identifier Source: org_study_id
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