Clinical trial NCT04933136: Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radial Artery Occlusion
Keywords: Radial Artery Occlusion
Transradial approach
Transulnar approach
Dual artery hemostasis
Patent hemostasis
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of radial artery occlusion
timeFrame: 30 - 270 minutes after catheterization
measure: Total time to hemostasis
timeFrame: 30 - 270 minutes after catheterization or until hemostasis is achieved
Secondary outcomes:
measure: Change in patient comfort rating
timeFrame: During procedure
measure: Rate of access site complications
timeFrame: up to 30 days after catheterization
measure: Total nursing time involvement
timeFrame: During hemostasis up to 24 hours after catheterization.
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
facility: CSSS Chicoutimi
state: Quebec
city: Montréal
country: Canada
facility: CHUM- Centre hospitalier de l'Université de Montréal
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec
state: Quebec
city: Québec
country: Canada
facility: IUCPQ - Laval Hospital
state: Quebec
city: Trois-Rivières
country: Canada
facility: Hôpital Sainte-Marie
state: Quebec
Study officials:
References: