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

Olivier F. Bertrand

Status: Unknown

Conditions: Radial Artery Injury

Treatments: Device: Hemostasis

Study type: Interventional

Funder types: Other

Identifiers

NCT04439513

2020-3400, 21885

EASY-RAO

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Dual Artery Compression

Experimental group

Description:

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.

Treatment:

Device: Hemostasis

Radial Artery-Only

Active Comparator group

Description:

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.

Treatment:

Device: Hemostasis