About this trial
This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The study aims to assess rates of ischemic and bleeding adverse events.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
the total target vessels ≤2 and a total of target lesions ≤2.
Total length of DCB used for target lesions <60 mm.
Disqualifiers
Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
Treatment with a bioabsorbable stent at any time prior to index PCI.
Acute myocardial infarction with ST-segment elevation within the past two weeks.
Trial design
Treatments tested in this trial
- Drug-coated balloon
- Single antiplatelet therapy (SAPT)
- Dual antiplatelet therapy (DAPT)
Treatment groups
Sponsors and collaborators
Gan Lijun
Lead sponsor
Affiliated Hospital of Jining Medical University
Sponsor institution