Status:
UNKNOWN
BioFreedom™ BA9™ Ultra
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Biosensors International
Conditions:
Cardiovascular Death
Myocardial Infarction
Eligibility:
All Genders
Brief Summary
The purpose of the study is to assess the safety and efficacy of the BioFreedom Ultra stent for treatment of STEMI patients. Besides, in patients who are clinically indicated for a stage procedure, In...
Detailed Description
Coronary artery disease (CAD) is the leading cause of death and disability worldwide. One severe manifestation of CAD is acute ST elevation myocardial infarction (STEMI) which is commonly due to ather...
Eligibility Criteria
Inclusion
- STEMI patients treated with one or several BioFreedom stent(s)
- Patients who agree to comply with the follow up requirements.
- Patients with a life expectancy of \> 1 year at time of consent.
- Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.
Exclusion
- Patients in cardiogenic shock
- Any out of hospital cardiac arrest
- Glasgow score \< 15
- Patients unable or unwilling to give documented informed consent
- Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
July 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 21 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05331547
Start Date
July 21 2021
End Date
January 21 2024
Last Update
April 15 2022
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong