Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.

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.

• 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.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Occlusion
• Intervention / Treatment: Device: Terry2 Band

Detailed Description

Radial Artery Occlusion (RAO) is the most common peri-procedural complication after a trans-radial catheterization,

Although usually asymptomatic, RAO may prevent the use of radial artery access in future catheterization should the patient need one; the use And the artery cannot be used as an alternate graft in case the patient is referred for aorto-coronary bypass surgery.

Recent data has demonstrated a clinical benefit for the use of radial artery over a venous graft for patients requiring artery bypass grafts.

Current international recommendations suggest limiting the risk of RAO to less than 5% upon discharge from hospital. To do this a change of method, ie performing a non-occlusive hemostasis of the radial artery is the most effective method to limit the risk of RAO. Unfortunately, this method takes time and requires repeated interventions by nurses, which has limited its application worldwide. In addition, simple hemostasis systems (on radial artery alone) can only achieve non-occlusive hemostasis in 60-75% of cases.

On the other hand, it has been shown that by applying simultaneous pressure to the two arteries of the wrist (the radial artery and the cubital artery), one could obtain a non-occlusive hemostasis of the radial artery in more than 95% of cases and the level of RAO was reduced < 2%. However, the handling of 2 separate hemostasis systems again requires repeated intervention by the nursing staff and therefore burdens the monitoring procedure.

The device Terry2™ band applies simultaneous differential compression to the radial artery and the cubital artery. Its mechanism of action aims to accelerate the time of hemostasis, reduce nursing work, improve patient comfort and minimize the risk of radial artery occlusion during and after hemostasis.

Hypotheses:

• The Terry2™ band provides fast and safe non-occlusive radial hemostasis that limits the risk of RAO.
• The Terry2™ band is associated with increased patient comfort, reduced staff work and a minimized risk of RAO after radial catheterization.

Procedures:

At the end of the radial approach procedure, patients will have a Terry2 band installed™ according to the instructions for use. Staff will be trained on the use of the device by means of an educational video. Once the device is installed, a check for the presence of non-occlusive hemostasis will be done before the patient has returned to their room.

Once the hemostasis is completed, the permeability of the radial artery is again checked by pulse oximetry. In case of doubt about the permeability of the instrumented artery, it is recommended to validate with an ultrasound-doppler.

Rates of RAO and other access site complications, total nursing time involved and patient comfort will be evaluated.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Tomas A Cieza Lara, MD; Phone Number: 4666 +1 481 6568711; Email: tomas.cieza@criucpq.ulaval.ca
• Study Contact Backup: Name: Michèle Jadin; Email: michele.jadin@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Not yet recruiting
      • CSSS Chicoutimi
      • Contact: Francis Bonenfant
      • Principal Investigator: Francis Bonenfant, MD
    • Montréal, Quebec, Canada
      • Not yet recruiting
      • CHUM- Centre hospitalier de l'Université de Montréal
      • Contact: Samer Mansour
      • Contact: Adriana Carbonaro
    • Québec, Quebec, Canada
      • Not yet recruiting
      • CHU de Québec
      • Contact: Jimmy MacHaalany
    • Québec, Quebec, Canada
      • Recruiting
      • IUCPQ - Laval Hospital
      • Contact: Tomas A Cieza Lara, MD
      • Principal Investigator: Tomas A. Cieza Lara, MD
    • Trois-Rivières, Quebec, Canada
      • Not yet recruiting
      • Hôpital Sainte-Marie
      • Contact: Vincent Spagnoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient comfort rating	Change on patient comfort/pain perception measured by a visual analog scale (VAS) before placing the device and after its removal. The VAS used ranges from 0 to 10, where the lower scores refer to lower pain and higher comfort. 0 -1 Very comfortable / No pain 2 -3 Comfortable / Mild pain 4 - 5 Somewhat comfortable / Moderate Pain 6 - 7 Somewhat uncomfortable / Severe Pain 8 - 9 Uncomfortable / Very severe pain 10- Very uncomfortable / Extreme pain	During procedure
Rate of access site complications	Using the EASY scale for hematoma and bleeding	up to 30 days after catheterization
Total nursing time involvement	Total nursing time dedicated to care for access site until hemostasis is achieved. Calculated as as a combination of the number of interventions and time per intervention.	During hemostasis up to 24 hours after catheterization.

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Radial Artery Occlusion; Transradial approach; Transulnar approach; Dual artery hemostasis; Patent hemostasis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: Registry-Terry2 Band

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No