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

NCT ID: NCT04439513

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radial Artery Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Hemostasis

Intervention Type DEVICE

Compression device to achieve hemostasis.

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.

Group Type ACTIVE_COMPARATOR

Hemostasis

Intervention Type DEVICE

Compression device to achieve hemostasis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemostasis

Compression device to achieve hemostasis.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Olivier F. Bertrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olivier F. Bertrand

Director of the International Chair on Interventional Cardiology and Transradial Approach

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IUCPQ - Laval Hospital

Québec, , Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olivier F Bertrand

Role: CONTACT

4186568711

Michèle Jadin

Role: CONTACT

4186568711 ext. 3007

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olivier F Bertrand, MD PhD

Role: primary

418 656 8711

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-3400, 21885

Identifier Type: OTHER

Identifier Source: secondary_id

EASY-RAO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The AT-REBOA Target Trial
NCT06312436 COMPLETED
Thoracoabdominal Aortic Aneurysms
NCT06267573 NOT_YET_RECRUITING