Postcath Radial Arterial Clamp Time In the CAth Lab

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Vascular compression device- RADAR TM-Short clamp time; Device: Vascular compression device RADAR TM-Long clamp time

• Registration Number: NCT02269722
• Lead Sponsor: Lawson Health Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-28
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Clamp time	Vascular compression device- RADAR TM-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.
Long Clamp Time	Vascular compression device RADAR TM-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.

Primary Outcome Measures

Name	Time	Method
Incidence of radial artery occlusion	24 hours	Flow assessed by pulse oximeter

Secondary Outcome Measures

Name	Time	Method
Bleeding	24 hours	Need to retighten clamp, ooze, hematoma

Trial Locations

Locations (1)

London Health Science Center; 🇨🇦 London, Ontario, Canada