Coronary Heart Disease (CHD)
Conditions
Keywords
Coronary Heart Disease, Drug-Coated Balloon Angioplasty, P2Y12 Inhibitor Monotherapy, Non-Inferiority Clinical Trial
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDrug-coated balloon
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.
Sponsors
Gan Lijun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
Intervention model description
Prospective, multi-center, open-label, randomized controlled, noninferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria： 1. Age ≥ 18 years. 2. target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation). 3. the total target vessels ≤2 and a total of target lesions ≤2. 4. Total length of DCB used for target lesions \<60 mm. 5. The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset \>2 weeks. 6. All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis \<30%. 7. At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred. 8. All PCI stages have been completed (if applicable), and no further PCI procedures are planned. Inclusion criteria at the randomization visit within 24 hours post-index PCI: At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met: The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.
Exclusion criteria
Patients will be ineligible if they meet any of the following criteria: 1. Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI). 2. Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it. 3. Treatment with a bioabsorbable stent at any time prior to index PCI. 4. Acute myocardial infarction with ST-segment elevation within the past two weeks. 5. True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation). 6. Chronic total occlusion of the target lesion (≥3 months). 7. Unprotected left main coronary artery. 8. Thrombus present in the target lesion (imaging/visual). 9. Total length of DCB used in the target lesion ≥60 mm. 10. Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization. 11. Indications for long-term oral anticoagulation therapy. 12. Life expectancy of less than 1 year. 13. Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus. 14. Currently participating in another trial and has not yet reached the primary endpoint. 15. History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs). 16. Pregnant or breastfeeding women. 17. Inability to understand and follow study-related instructions or to comply with the study protocol. 18. Inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization | 12 months after randomization | Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patients 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, and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1, 3, 6, 12 and 24 months after randomization | 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. |
| Patient-oriented composite endpoint (PoCE) | 1, 3, 6, 12 and 24 months after randomization | Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization. |
| Device-oriented Composite Endpoint (DoCE) | 1, 3, 6, 12 and 24 months after randomization | Composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CI-TLR) |
Countries
China
Contacts
CONTACTYong Cao
Outcome results
None listed