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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGan Lijun

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

2,170 Participants
are divided into 2 treatment groups

Locations

3
Shandong Provincial Third Hospital JinanShandong, China
Affiliated Hospital of Jining Medical University272029, JiningShandong, China
Qingdao Municipal Hospital QingdaoShandong, China

Sponsors and collaborators

Gan Lijun

Lead sponsor

Affiliated Hospital of Jining Medical University

Sponsor institution