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

Radial Artery Injury Clinical Trial

— EASY-RAO  

Official title:

Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04439513
• Other study ID #: EASY-RAO
• Secondary ID: 2020-3400, 21885
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Laval University
• Contact: Olivier F Bertrand
• Phone: 4186568711
• Email: olivier.bertrand[@]crhl.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Radial Artery Injury

Intervention

Device:
• Hemostasis
Compression device to achieve hemostasis.

Locations

Country	Name	City	State
Canada	IUCPQ - Laval Hospital	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Olivier F. Bertrand

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of radial artery patent-hemostasis during hemostasis	To determine the conservation of blood flow through the radial artery during compressive hemostasis	throughout intervention, up to 180 minutes
Secondary	Patient comfort during hemostasis as assessed on a visual scale	To evaluate the level of patient comfort in relation to the device used	throughout intervention, up to 30 days
Secondary	Rates of complications such as repeat bleeding and hematoma (EASY Scale)	To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.	throughout intervention, up to 30 days
Secondary	Nursing involvement in hemostasis management for sensitivity analysis on cost assessment	To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation.	throughout intervention, up to 24 hours