A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Subjects must be between 18 and 80 years of age
• Subject must present with acute myocardial infarction or unstable angina planned for PCI
• Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
• Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR \>0.8
• Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
• Target lesion must have any two of the intravascular imaging criteria of PB \>65%, MLA \<3.5 mm\^2 (OCT) or 4.0mm\^2 (IVUS), FCT \<75 μm, or maximal lipid arc \>180°
• Subject must provide written informed consent before any study-related procedure
Locations
Other Locations
China
Affiliated Beijing Luhe Hospital of Capital Medical University
NOT_YET_RECRUITING
Beijin
The Third Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Dalian Municipal Central Hospital
NOT_YET_RECRUITING
Dalian
The First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Daqing Oilfield General Hospital
NOT_YET_RECRUITING
Daqing
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The Affiliated Hospital of Neimenggu Medical University
NOT_YET_RECRUITING
Hohhot
The First Affiliated Hospital of Jiamusi University
NOT_YET_RECRUITING
Jiamusi
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
Affiliated Hospital of Jining Medical University
NOT_YET_RECRUITING
Jining
Mudanjiang Cardiovascular Hospital
NOT_YET_RECRUITING
Mudanjiang
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
The People's Hospital of Liaoning Province
NOT_YET_RECRUITING
Shengyang
Tongji Hospital Tongji Medical College of HUST
NOT_YET_RECRUITING
Wuhan
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Haibo Jia, PhD
jhb101180@163.com
15945685291
Time Frame
Start Date:2024-04-16
Estimated Completion Date:2030-12
Participants
Target number of participants:1860
Treatments
Experimental: DCB treatment
Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment.
Active_comparator: Guideline-directed medical treatment
Non-flow limited vulnerable plaque will be left with no intervention when the individual is randomized into guideline-directed medical treatment group. The individual will receive guideline-directed medical treatment alone.