Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.
A Prospective Registry for the Evaluation of the Safety, Efficacy and Clinical Impact of the Double Hemostasis System Terry2 (TM) on Patients Undergoing a Trans-radial or Trans-cubital Catheterism.
Laval University
500 participants
Dec 12, 2022
OBSERVATIONAL
Conditions
Summary
* Improving patient comfort and implementing the protocols required to minimize the risk of RAO must be part of quality control. * Several procedural parameters are related to the risk of RAO but hemostasis is a critical period. * Despite the fact that non-occlusive hemostasis of the radial artery is a recognized and effective technique for reducing the risk of RAO, it is rarely practiced because it is tedious, involves additional care and is not always effective with current hemostasis systems. * Prophylactic compression of the cubital artery during radial artery hemostasis has been shown to be effective in maintaining non-occlusive hemostasis but requires 2 devices and does not simplify care procedures. * The Terry2™ band is a new dual device that offers effortless non-occlusive radial hemostasis and does not require repeated intervention by nursing staff. The primary objectives of this observational study are to demonstrate the benefits, safety and impact on care of using Terry2™ band in patients undergoing diagnostic or interventional catheterization by radial (or ulnar) approach.
Eligibility
Inclusion Criteria1
- Any patient referred for diagnostic or interventional catheterization through radial or cubital approach
Exclusion Criteria4
- Unable to understand the study design and sign an informed consent
- Unable to receive antiplatelet therapy with aspirin and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant treatment with heparin or bivalirudin
- Presence of any local conditions like hematoma or pseudo-aneurysms precluding radial or cubital access.
- Presence of PPG while simultaneously compressing the radial and cubital arteries (due to collateral branches or interosseous artery), which prevents the establishment of non-occlusive hemostasis with the Terry2(TM) band.
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Interventions
Hemostasis protocol following radial or cubital approach catheterization using the dual artery hemostasis device Terry2Band.
Locations(5)
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NCT04933136