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Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Sponsor: Harbin Medical University
Summary
The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.
Official title: A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1860
Start Date
2024-04-16
Completion Date
2030-12
Last Updated
2024-05-22
Healthy Volunteers
No
Conditions
Interventions
Drug-coated balloon
Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.
Guideline-directed medical treatment
All individuals will receive guideline-directed medical treatment.
Locations (18)
Affiliated Beijing Luhe Hospital of Capital Medical University
Beijin, Beijing Municipality, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, China
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China
The Third Second Hospital of Jilin University
Changchun, Jilin, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The People's Hospital of Liaoning Province
Shengyang, Liaoning, China
The Affiliated Hospital of Neimenggu Medical University
Hohhot, Neimenggu, China
Shandong Provincial Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China