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

Sponsor

Olivier F. Bertrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT04439513

Collaborator

(none)

100

Enrollment

Location

Arms

29.4

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Injury	Device: Hemostasis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Jun 18, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual Artery Compression 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 Compression device to achieve hemostasis.
Active Comparator: Radial Artery-Only 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 Compression device to achieve hemostasis.

Arm

Intervention/Treatment

Experimental: Dual Artery Compression

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

Compression device to achieve hemostasis.

Active Comparator: Radial Artery-Only

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

Compression device to achieve hemostasis.

Outcome Measures

Primary Outcome Measures

Rate of RAO after transradial approach (TRA) at hospital discharge [up to 24 hours]
To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.

Secondary Outcome Measures

Percentage of radial artery patent-hemostasis during hemostasis [throughout intervention, up to 180 minutes]
To determine the conservation of blood flow through the radial artery during compressive hemostasis
Patient comfort during hemostasis as assessed on a visual scale [throughout intervention, up to 30 days]
To evaluate the level of patient comfort in relation to the device used
Rates of complications such as repeat bleeding and hematoma (EASY Scale) [throughout intervention, up to 30 days]
To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.
Nursing involvement in hemostasis management for sensitivity analysis on cost assessment [throughout intervention, up to 24 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IUCPQ - Laval Hospital	Quebec		Canada	G1V 4G5

Sponsors and Collaborators

Olivier F. Bertrand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olivier F. Bertrand, Director of the International Chair on Interventional Cardiology and Transradial Approach, Laval University

ClinicalTrials.gov Identifier:

NCT04439513

Other Study ID Numbers:

EASY-RAO
2020-3400, 21885

First Posted:

Jun 19, 2020

Last Update Posted:

Jan 31, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Olivier F. Bertrand, Director of the International Chair on Interventional Cardiology and Transradial Approach, Laval University

RAO

Hemostasis

TRA

Additional relevant MeSH terms:

Hemostatics

Study Results

No Results Posted as of Jan 31, 2022