Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)

NCT04439513 | Unknown

• 2 other identifiers: EASY-RAO2020-3400, 21885
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).

Conditions

Radial Artery Injury

Keywords

RAO; Hemostasis; TRA

Outcome Measures

Primary Outcomes (1)

• Rate of RAO after transradial approach (TRA) at hospital discharge

  To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.

  up to 24 hours

Secondary Outcomes (4)

• Percentage of radial artery patent-hemostasis during hemostasis

  throughout intervention, up to 180 minutes

• Patient comfort during hemostasis as assessed on a visual scale

  throughout intervention, up to 30 days

• Rates of complications such as repeat bleeding and hematoma (EASY Scale)

  throughout intervention, up to 30 days

• Nursing involvement in hemostasis management for sensitivity analysis on cost assessment

  throughout intervention, up to 24 hours

Study Arms (2)

Dual Artery Compression

EXPERIMENTAL

time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis.

Device: Hemostasis

Radial Artery-Only

ACTIVE COMPARATOR

time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis.

Device: Hemostasis

Interventions

Hemostasis DEVICE

Compression device to achieve hemostasis.

Dual Artery Compression; Radial Artery-Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)

You may not qualify if:

• Patient unable to understand study design or objectives
• Unable to sign informed consent
• Patient taking warfarin or other anticoagulant therapy
• Chronic RAO on both sides precluding TRA
• Previous ipsilateral transradial approach
• Inability to comply with the study follow-up
• Presence of plethysmographic waveform with radial and ulnar occlusive compression
• Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.

Sponsors & Collaborators

• Olivier F. Bertrand: lead

Study Sites (1)

IUCPQ - Laval Hospital

Québec, G1V 4G5, Canada

RECRUITING

Central Study Contacts

Olivier F Bertrand

CONTACT

4186568711; olivier.bertrand@crhl.ulaval.ca

Michèle Jadin

CONTACT

4186568711

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the International Chair on Interventional Cardiology and Transradial Approach

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: June 18, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)