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Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.

ConditionRadial Artery Occlusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaval University

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Terry2 Band

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
30 - 270 minutes after catheterization
2

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.

Time frame
30 - 270 minutes after catheterization or until hemostasis is achieved

Secondary outcomes

1

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

Time frame
During procedure
2

Rate of access site complications

Using the EASY scale for hematoma and bleeding

Time frame
up to 30 days after catheterization
3

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.

Time frame
During hemostasis up to 24 hours after catheterization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Source ClinicalTrials.gov
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