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

NCT07587099 | Recruiting DMC

• 1 other identifier: JYFY-CV-001
• Study Type: interventional
• Target: 2,170
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Coronary Heart Disease (CHD)

Keywords

Coronary Heart Disease; Drug-Coated Balloon Angioplasty; P2Y12 Inhibitor Monotherapy; Non-Inferiority Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization

  Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) without stent implantation assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of all-cause mortality, myocardial infarction, stroke, and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.

  12 months after randomization

Secondary Outcomes (3)

• Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)

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

• Patient-oriented composite endpoint (PoCE)

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

• Device-oriented Composite Endpoint (DoCE)

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

Study Arms (2)

Single antiplatelet therapy

EXPERIMENTAL

Device: Drug-coated balloon; Drug: Single antiplatelet therapy (SAPT)

Dual antiplatelet therapy

ACTIVE COMPARATOR

Device: Drug-coated balloon; Drug: Dual antiplatelet therapy (DAPT)

Interventions

Drug-coated balloon DEVICE

Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.

Dual antiplatelet therapy; Single antiplatelet therapy

Single antiplatelet therapy (SAPT) DRUG

The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.

Single antiplatelet therapy

Dual antiplatelet therapy (DAPT) DRUG

The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.

Dual antiplatelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset \>2 weeks.
• All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis \<30%.
• At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred.
• All PCI stages have been completed (if applicable), and no further PCI procedures are planned.
• At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met:
• The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.

You may not qualify if:

• Patients will be ineligible if they meet any of the following criteria:
• 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.
• True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).
• Chronic total occlusion of the target lesion (≥3 months).
• Unprotected left main coronary artery.
• Thrombus present in the target lesion (imaging/visual).
• Total length of DCB used in the target lesion ≥60 mm.
• Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization.
• Indications for long-term oral anticoagulation therapy.
• Life expectancy of less than 1 year.
• Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus.
• Currently participating in another trial and has not yet reached the primary endpoint.

Sponsors & Collaborators

• Gan Lijun: lead

Study Sites (14)

Beijing Luhe Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

NOT YET RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Heze Municipal Hospital

Heze, Shandong, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Shandong Provincial Third Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272029, China

RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, China

NOT YET RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

NOT YET RECRUITING

Tai'an City Central Hospital

Tai’an, Shandong, China

NOT YET RECRUITING

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

NOT YET RECRUITING

Shanghai Fengxian District People's Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

NOT YET RECRUITING

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MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Yong Cao

CONTACT

+86-0537-2905210; caoyong0419@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: Prospective, multi-center, open-label, randomized controlled, noninferiority trial

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Locations

CN (14)