Vascular healing after the BioFreedom drug coated stent implantation in patients with acute coronary syndrome: HEAL-BioFreedom ACS study
- Conditions
- Acute coronary syndrome
- Registration Number
- JPRN-UMIN000034769
- Lead Sponsor
- Department of Cardiology, Osaka Police Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Pregnant and breastfeeding women 2. Patients expected not to comply with 1 month DAPT 3. Patients requiring a planned staged PCI procedure more than two weeks after the index procedure 4. Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy 5. Active bleeding at the time of inclusion 6. Reference vessel diameter less than 2.25 or more than 4.0mm 7. Cardiogenic shock 8. Compliance with long-term single anti-platelet therapy unlikely 9. Known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, umirolimus (also known as biolimus A9) or a sensitivity to contrast media, which cannot be adequately pre-medicated 10. PCI during the previous 6 months for a stable lesion other than the target lesion of the index procedure OR PCI during the previous 12 months for a ACS lesion other than the target lesion of the index procedure 11. Participation in another clinical trial (up to 12 months after index procedure) 12. Patients with a life expectancy of less than 1 year
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method