Status:
COMPLETED
Ultrasound Comparison of Radial Artery Hyperplasia After Use of a 7F Sheathless Guide vs. 6F Sheath/Guide Combination
Lead Sponsor:
Tallahassee Research Institute, Inc.
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the routine use of a sheathless 7F guide catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F sheath/guide combinat...
Detailed Description
The purpose of the PRAGMATIC study (A Prospective Randomized Trial comparing Radial Artery Intimal Hyperplasia resulting from a 7F Transradial Sheathless Guide \[Mach 1\] vs. a 6F Transradial Sheath/G...
Eligibility Criteria
Inclusion
- Age 18 or above with coronary artery disease
- Scheduled for transradial PCI
Exclusion
- Has had prior transradial access for heart catheterization or PCI in same radial artery as planned access site
- Not willing to undergo follow-up ultrasound examinations
- Acute ST elevation myocardial infarction or other emergent PCI
- Inability to provide informed consent
Key Trial Info
Start Date :
February 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03271177
Start Date
February 25 2016
End Date
March 13 2017
Last Update
September 1 2017
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