Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07587099

Single vs. Dual Antiplatelet Therapy in Chronic Coronary Syndrome and Stable Acute Coronary Syndrome Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (KONG-FREEDOM-I)

Led by Gan Lijun · Updated on 2026-05-19

2170

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of single antiplatelet therapy (SAPT) using a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) for patients with chronic coronary syndrome (CCS) and stable acute coronary syndrome (S-ACS). This trial focuses on patients undergoing percutaneous coronary intervention (PCI) using the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The goal is to assess rates of ischemic and bleeding events in these patients. Participants receive treatment with a drug-coated balloon (Fireliums rapamycin-eluting coronary balloon) after pre-dilatation during PCI. Patients are then randomly assigned to either single antiplatelet therapy (using drugs like ticagrelor or clopidogrel) or dual antiplatelet therapy based on the patient's clinical characteristics. The study is open-label and multicenter, with no stent implant used in the treated vessels. During the study, participants will be monitored for adverse clinical events, especially focusing on net adverse clinical events (NACE) at 12 months after randomization. Other outcomes include bleeding events, patient-oriented composite endpoints, and device-oriented composite endpoints, tracked at intervals up to 24 months. Assessments include clinical follow-up and safety monitoring over this period to evaluate the treatments' impact and patient health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Successfully underwent PCI with drug-coated balloon treatment without stent implantation
  • Target lesion in vessels with diameter between 2.0 and 4.5 mm
  • Total of 2 or fewer target vessels and lesions
  • Total length of drug-coated balloon used for target lesions less than 60 mm
  • Indication for PCI includes chronic coronary syndrome and stable acute coronary syndrome (including silent ischemia, stable angina, unstable angina, NSTEMI, or STEMI onset over 2 weeks ago)
  • All lesions treated successfully with drug-eluting balloon with post-procedural diameter stenosis less than 30%
  • No flow-limiting angiographic complications requiring extended dual antiplatelet therapy
  • All PCI stages completed and no further PCI planned
  • Uneventful clinical course within 24 hours post-index PCI with no myocardial infarction, symptomatic restenosis, device-related thrombus, stroke, or revascularization requiring extended dual antiplatelet therapy
Not Eligible

You will not qualify if you...

  • Stent implantation within 6 months prior to index PCI
  • Treatment for in-stent thrombosis at or within 6 months prior to index PCI
  • Treatment with bioabsorbable stent before index PCI
  • Acute myocardial infarction with ST-segment elevation within past 2 weeks
  • True bifurcation lesions requiring two stents with branch vessel diameter 2.5 mm or greater
  • Chronic total occlusion of target lesion lasting 3 months or more
  • Unprotected left main coronary artery
  • Thrombus present in target lesion
  • Total length of drug-coated balloon used 60 mm or more
  • Active bleeding requiring medical intervention at randomization
  • Indication for long-term oral anticoagulation therapy
  • Life expectancy less than 1 year
  • Allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus
  • Currently participating in another trial without reaching primary endpoint
  • History of asthma induced by salicylates or similar substances
  • Pregnant or breastfeeding women
  • Inability to understand or follow study instructions or protocol
  • Inability to provide written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo percutaneous coronary intervention using a drug-coated balloon without stent implantation.

1 procedure visit

Treatment

Duration - Up to 12 months

Participants receive either single antiplatelet therapy or dual antiplatelet therapy based on randomization to prevent blood clots after the procedure.

Regular visits during the treatment period as per clinical protocol

Follow-up

Duration - Up to 24 months after randomization

Participants are monitored for clinical outcomes including bleeding events and adverse cardiac events after completing treatment.

Visits at 1, 3, 6, 12, and 24 months after randomization

Trial Site Locations

Total: 3 locations

1

Shandong Provincial Third Hospital

Jinan, Shandong, China

Not Yet Recruiting

2

Affiliated Hospital of Jining Medical University

Jining, Shandong, China, 272029

Actively Recruiting

3

Qingdao Municipal Hospital

Qingdao, Shandong, China

Not Yet Recruiting

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Research Team

Y

Yong Cao

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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https://pubmed.ncbi.nlm.nih.gov/36682076

Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.

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Raban V Jeger, Ahmed Farah, Marc-Alexander Ohlow...

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Raban V Jeger, Ahmed Farah, Marc-Alexander Ohlow...

https://pubmed.ncbi.nlm.nih.gov/33091360

Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review.

Hasan Mohiaddin, Tamar D F K Wong, Anne Burke-Gaffney...

https://pubmed.ncbi.nlm.nih.gov/30368735