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Recruiting
NCT07587099
Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)
Conditions: Coronary Heart Disease (CHD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 2170
Sponsor: Gan Lijun
Location: Beijing Luhe Hospital Beijing Beijing Municipality
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07587099). StuddyBuddy aggregates publicly available trial information.
