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RECRUITING
NCT07587099
NA

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

Sponsor: Gan Lijun

View on ClinicalTrials.gov

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.

Official title: An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2170

Start Date

2026-05-04

Completion Date

2030-12-31

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

DEVICE

Drug-coated balloon

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.

DRUG

Single antiplatelet therapy (SAPT)

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.

DRUG

Dual antiplatelet therapy (DAPT)

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.

Locations (14)

Beijing Luhe Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Heze Municipal Hospital

Heze, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Shandong Provincial Third Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Tai'an City Central Hospital

Tai’an, Shandong, China

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

Shanghai Fengxian District People's Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China