Status:
UNKNOWN
Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial
Lead Sponsor:
NPO International TRI Network
Collaborating Sponsors:
European Cardiovascular Research Center
Duke Clinical Research Institute
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic co...
Eligibility Criteria
Inclusion
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
- Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patient who can accept radial access.
Exclusion
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Hemodialysis patient
- STEMI
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT02269449
Start Date
October 1 2014
End Date
April 1 2015
Last Update
October 21 2014
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