Clinical Research Directory
Browse clinical research sites, groups, and studies.
Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)
Sponsor: Gan Lijun
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
Conditions
Interventions
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.
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.
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