Recruiting

Radial Artery Occlusion

Sponsor:

Laval University

Code:

NCT04933136

Conditions

Radial Artery Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Terry2 Band

Study Details

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.

Conditions

Radial Artery Occlusion

Study ID

NCT04933136

Start date

Dec 12, 2022

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Terry2 Band

Hemostasis protocol following radial or cubital approach catheterization using the dual artery hemostasis device Terry2Band.

Primary outcome measure

  • Rate of radial artery occlusion [ Time Frame: 30 - 270 minutes after catheterization ]
  • Total time to hemostasis [ Time Frame: 30 - 270 minutes after catheterization or until hemostasis is achieved ]

Central Contacts and Locations

Central contacts

Tomas A Cieza Lara, MD

+1 481 6568711tomas.cieza@criucpq.ulaval.ca

Michèle Jadin

michele.jadin@criucpq.ulaval.ca

Locations

IUCPQ - Laval Hospital

Recruiting

Québec, Quebec, Canada

Principal Investigator:

Tomas A. Cieza Lara, MD

More Information

Sponsor

Laval University

Last update posted

Mar 10, 2025

Last verified

Mar, 2025

Keywords

  • Radial Artery Occlusion
  • Transradial approach
  • Transulnar approach
  • Dual artery hemostasis
  • Patent hemostasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-03-10.