NCT04933136 Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.
| NCT ID | NCT04933136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Radial Artery Occlusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-12-12 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Any patient referred for diagnostic or interventional catheterization through radial or cubital approach Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04933136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radial Artery Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04933136 currently recruiting?
Yes, NCT04933136 is actively recruiting participants. Contact the research team at tomas.cieza@criucpq.ulaval.ca for enrollment information.
Where is the NCT04933136 trial being conducted?
This trial is being conducted at Chicoutimi, Canada, Montreal, Canada, Québec, Canada, Québec, Canada and 1 additional location.
Who is sponsoring the NCT04933136 clinical trial?
NCT04933136 is sponsored by Laval University. The trial plans to enroll 500 participants.