Recruiting

Dual Artery Compression vs. Radial Artery-Only Hemostasis

Sponsor:

Olivier F. Bertrand

Code:

NCT04439513

Conditions

Radial Artery Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hemostasis

Study Details

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

Study ID

NCT04439513

Start date

Jun 18, 2020

Status verified date

Jan, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Hemostasis

Compression device to achieve hemostasis.

Primary outcome measure

  • Rate of RAO after transradial approach (TRA) at hospital discharge [ Time Frame: up to 24 hours ]

Central Contacts and Locations

Central contacts

Olivier F Bertrand

4186568711olivier.bertrand@crhl.ulaval.ca

Michèle Jadin

4186568711

Locations

IUCPQ - Laval Hospital

Recruiting

Quebec, Canada, G1V 4G5

Contacts

Olivier F Bertrand, MD PhD

418 656 8711olivier.bertrand@crhl.ulaval.ca

Principal Investigator:

Olivier F Bertrand, MD PhD

More Information

Sponsor

Olivier F. Bertrand

Last update posted

Jan 31, 2022

Last verified

Jan, 2022

Keywords

  • RAO
  • Hemostasis
  • TRA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olivier F. Bertrand on 2022-01-31.