Postcath Radial Arterial Clamp Time In the CAth Lab

NCT ID: NCT02269722

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 564 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

Brief Summary

The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.

Detailed Description

The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short Clamp time

Radial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed.

Group Type: EXPERIMENTAL

Vascular compression device- RADAR TM-Short clamp time

Intervention Type: DEVICE

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Long Clamp Time

Radial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one.

Group Type: EXPERIMENTAL

Vascular compression device RADAR TM-Long clamp time

Intervention Type: DEVICE

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Interventions

Vascular compression device- RADAR TM-Short clamp time

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Intervention Type: DEVICE

Vascular compression device RADAR TM-Long clamp time

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
• Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
• Patients must be able to give informed consent

Exclusion Criteria

• Evidence of pre-procedural radial artery thrombosis
• Inability to give informed consent
• Patient desire not to participate in the study
• Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Shahar Lavi

Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahar Lavi, MD

Role: PRINCIPAL_INVESTIGATOR

LHSC

Locations

London Health Science Center

London, Ontario, Canada

Countries

Canada

References

Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.

Reference Type: DERIVED

PMID: 28159821 (View on PubMed)

Other Identifiers

10796

Identifier Type: -

Identifier Source: org_study_id