Postcath Radial Arterial Clamp Time In the CAth Lab

Coronary Artery Disease Clinical Trial

— PRACTICAL  

Official title:

A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269722
• Other study ID #: 10796
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2014
• Last updated: October 4, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Vascular compression device- RADAR TM-Short clamp time
A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
• Vascular compression device RADAR TM-Long clamp time
A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Locations

Country	Name	City	State
Canada	London Health Science Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of radial artery occlusion	Flow assessed by pulse oximeter	24 hours	Yes
Secondary	Bleeding	Need to retighten clamp, ooze, hematoma	24 hours	Yes