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

Sponsors and collaborators

Gan Lijun

Lead sponsor

Affiliated Hospital of Jining Medical University

Sponsor institution