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.
The purpose of the KONG-FREEDOM-I study is to evaluate the efficacy and safety of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor after successful PCI with the Fireliums coronary rapamycin drug-eluting balloon without stent implantation in coronary artery disease in vessels with a diameter between 2.0 and 4.5 mm, compared to routine dual antiplatelet therapy (DAPT). Patients with chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) will be enrolled and randomized in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,170
Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor)therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.
Shandong Provincial Third Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGAffiliated Hospital of Jining Medical University
Jining, Shandong, China
RECRUITINGQingdao Municipal Hospital
Qingdao, Shandong, China
NOT_YET_RECRUITINGRate of Net Adverse Clinical Events (NACE) at 12 months after randomization
Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patient undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) without stent implantation assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of all-cause mortality, myocardial infarction, stroke, clinically driven target lesion revascularization (CD-TLR), and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.
Time frame: 12 months after randomization
Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)
Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) without stent implantation.
Time frame: 1, 3, 6, 12 and 24 months after randomization
Patient-oriented composite endpoint (PoCE)
Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization.
Time frame: 1, 3, 6, 12 and 24 months after randomization
Device-oriented Composite Endpoint (DoCE)
Composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CI-TLR)
Time frame: 1, 3, 6, 12 and 24 months after randomization
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