Back to resultsPostcath Radial Arterial Clamp Time In the CAth Lab (PRACTICAL)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Vascular compression device- RADAR TM-Short clamp time
Vascular compression device RADAR TM-Long clamp time
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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
Sites / Locations
- London Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Short Clamp time
Long Clamp Time
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of radial artery occlusion
Flow assessed by pulse oximeter
Secondary Outcome Measures
Bleeding
Need to retighten clamp, ooze, hematoma
Full Information
NCT ID
NCT02269722
First Posted
September 28, 2014
Last Updated
October 4, 2016
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02269722
Brief Title
Postcath Radial Arterial Clamp Time In the CAth Lab
Acronym
PRACTICAL
Official Title
A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short Clamp time
Arm Type
Experimental
Arm Description
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.
Arm Title
Long Clamp Time
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vascular compression device- RADAR TM-Short clamp time
Intervention Description
A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
Intervention Type
Device
Intervention Name(s)
Vascular compression device RADAR TM-Long clamp time
Intervention Description
A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
Primary Outcome Measure Information:
Title
Incidence of radial artery occlusion
Description
Flow assessed by pulse oximeter
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Bleeding
Description
Need to retighten clamp, ooze, hematoma
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Organizational Affiliation
LHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28159821
Citation
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.
Results Reference
derived
Learn more about this trial
Postcath Radial Arterial Clamp Time In the CAth Lab
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