Using a new device to prevent radial artery occlusion after catheterization
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 · NCT04933136
This study is testing a new band to see if it can help prevent blockage in the wrist artery after heart procedures, making it safer and more comfortable for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University (other) |
| Locations | 5 sites (Chicoutimi, Quebec and 4 other locations) |
| Trial ID | NCT04933136 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and safety of the Terry2™ band in achieving non-occlusive hemostasis of the radial artery after transradial catheterization. The study focuses on improving patient comfort and minimizing the risk of radial artery occlusion (RAO), a common complication that can limit future access to the artery. By applying simultaneous pressure to both the radial and cubital arteries, the Terry2™ band aims to reduce the incidence of RAO to less than 2%. The study will involve patients undergoing diagnostic or interventional catheterization through radial or cubital approaches.
Who should consider this trial
Good fit: Ideal candidates include patients referred for diagnostic or interventional catheterization via radial or cubital approaches.
Not a fit: Patients with local conditions like hematomas or pseudo-aneurysms that prevent radial or cubital access may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of radial artery occlusion, improving future access for catheterization and surgical procedures.
How similar studies have performed: While the concept of non-occlusive hemostasis has been explored, the use of the Terry2™ band represents a novel approach that has not been widely tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicoutimi, Quebec and 4 other locations
- CSSS Chicoutimi — Chicoutimi, Quebec, Canada (NOT_YET_RECRUITING)
- CHUM- Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
- CHU de Québec — Québec, Quebec, Canada (NOT_YET_RECRUITING)
- IUCPQ - Laval Hospital — Québec, Quebec, Canada (RECRUITING)
- Hôpital Sainte-Marie — Trois-Rivières, Quebec, Canada (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Tomas A Cieza Lara, MD
- Email: tomas.cieza@criucpq.ulaval.ca
- Phone: +1 481 6568711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radial Artery Occlusion, Transradial approach, Transulnar approach, Dual artery hemostasis, Patent hemostasis