Actively Recruiting

Age: 18Years +
All Genders
ID04933136

Evaluation of the Safety, Effectiveness, and Clinical Impact of the Terry2™ Dual Artery Hemostasis Device in Patients Undergoing Trans-radial or Trans-cubital Catheterization

Led by Laval University · Updated on 2025-03-10

500

Participants Needed

5

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the use of the Terry2™ band, a new dual artery hemostasis device, in patients undergoing diagnostic or interventional catheterization through radial or cubital artery access. Radial Artery Occlusion (RAO) is a common complication after trans-radial catheterization, which can limit future artery access or graft use. Current non-occlusive hemostasis methods reduce RAO risk but are time-consuming and require repeated nursing interventions, limiting their use. The study involves applying the Terry2™ band at the end of the catheterization procedure. This device compresses both the radial and cubital arteries simultaneously to achieve non-occlusive hemostasis more efficiently, aiming to speed up hemostasis, reduce nursing workload, and increase patient comfort. Staff will be trained via an educational video on how to use the device, and its application will be checked for effectiveness before the patient returns to their room. Participants will be monitored for the rate of RAO and other access site complications up to 30 days after catheterization. Researchers will also measure total time to hemostasis, patient comfort during the procedure, and nursing time involved up to 24 hours post-procedure. Radial artery patency will be checked by pulse oximetry and, if needed, confirmed by ultrasound Doppler. The total participation duration varies with the follow-up period extending up to one month.

CONDITIONS

Brief Title

Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any patient referred for diagnostic or interventional catheterization through radial or cubital approach
Not Eligible

You will not qualify if you...

  • 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 photoplethysmography (PPG) while simultaneously compressing the radial and cubital arteries, preventing non-occlusive hemostasis with the Terry2™ band

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Approximately 30 to 270 minutes after catheterization

Participants undergo catheterization via radial or cubital approach followed by application of the Terry2™ dual artery hemostasis device to achieve non-occlusive hemostasis.

1 visit (in-person) during catheterization and hemostasis

Monitoring

Duration - Up to 30 days

Participants are monitored for radial artery occlusion, access site complications, nursing time involvement, and patient comfort up to 30 days after catheterization.

Follow-up visits or assessments up to 30 days after catheterization

Trial Site Locations

Total: 5 locations

1

CSSS Chicoutimi

Chicoutimi, Quebec, Canada, G7H 5H6

Not Yet Recruiting

2

CHUM- Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Not Yet Recruiting

3

CHU de Québec

Québec, Quebec, Canada

Not Yet Recruiting

4

IUCPQ - Laval Hospital

Québec, Quebec, Canada

Actively Recruiting

5

Hôpital Sainte-Marie

Trois-Rivières, Quebec, Canada

Not Yet Recruiting

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Research Team

T

Tomas A Cieza Lara, MD

M

Michèle Jadin

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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