Clinical Trial

Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)

Study acronym: KONG-FREEDOM-I
Recruiting
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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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 3 -> 14 locations 2026-07-15
critical Recruitment opened 2026-05-20
Trial Details
NCT Number NCT07587099
Lead Sponsor Gan Lijun
Conditions Coronary Heart Disease (CHD)
Enrollment 2,170 participants
Start Date 2026-05-04
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-14