NCT04933136

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

June 12, 2021

Last Update Submit

March 5, 2025

Conditions

Radial Artery Occlusion

Keywords

Radial Artery OcclusionTransradial approachTransulnar approachDual artery hemostasisPatent hemostasis

Outcome Measures

Primary Outcomes (2)

  • Rate of radial artery occlusion

    Rate of radial artery occlusion throughout hemostasis until hospital discharge as measured by oximetry (photoplethysmography PPG) . The absence of a PPG curve indicates radial artery occlusion. Inconclusive cases maybe confirmed by doppler echography.

    30 - 270 minutes after catheterization

  • Total time to hemostasis

    Characterization of the total time required to obtain hemostasis of the access site after transradial catheterization using the Terry2 band. Measured from device installation until removal.

    30 - 270 minutes after catheterization or until hemostasis is achieved

Secondary Outcomes (3)

  • Change in patient comfort rating

    During procedure

  • Rate of access site complications

    up to 30 days after catheterization

  • Total nursing time involvement

    During hemostasis up to 24 hours after catheterization.

Interventions

Terry2 BandDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All comer adult population referred for diagnostic or interventional catheterization by transradial or transcubital approach at the participant centers.

You may qualify if:

  • Any patient referred for diagnostic or interventional catheterization through radial or cubital approach

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CSSS Chicoutimi

Chicoutimi, Quebec, G7H 5H6, 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

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Tomas A Cieza Lara, MD

CONTACT

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

Michèle Jadin

CONTACT

michele.jadin@criucpq.ulaval.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 21, 2021

Study Start

December 12, 2022

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

CA(5)