Actively Recruiting
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Led by Harbin Medical University · Updated on 2024-05-22
1860
Participants Needed
18
Research Sites
345 weeks
Total Duration
On this page
Sponsors
H
Harbin Medical University
Lead Sponsor
S
Shanghai Shenqi Medical Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of acute myocardial infarction or unstable angina planned for PCI
- Successful stent implantation with less than 20% residual stenosis in culprit lesions and ischemic lesions
- At least one native non-culprit lesion with 40-80% stenosis and QFR >0.8
- Target lesion diameter between 2.0 and 4.0 mm and length ≤ 50 mm
- Target lesion meets at least two imaging criteria: plaque burden >65%, minimum lumen area <3.5 mm² (OCT) or <4.0 mm² (IVUS), fibrous cap thickness <75 µm, or maximal lipid arc >180°
- Written informed consent provided before any study procedures
You will not qualify if you...
- Known allergy or contraindication to study drugs or device components, including aspirin, P2Y12 inhibitors, or paclitaxel, not manageable by pre-medication
- Receiving immunosuppressant therapy or having a severe autoimmune disease requiring chronic immunosuppression
- Experiencing hypotension, shock, or requiring mechanical support or intravenous vasopressors
- Creatinine clearance ≤30 ml/min/1.73 m²
- Left ventricular ejection fraction less than 30% within 30 days before procedure
- Life expectancy less than 2 years
- Currently participating in another investigational clinical study without primary endpoint completion
- Conditions limiting participation or compliance as judged by investigator
- Target lesion within 10 mm of a stent's end
- Target lesion in the left main coronary artery
- Target lesion in a bifurcation lesion with branch vessel diameter >2 mm and >50% stenosis
- Target lesion in severely calcified or tortuous vessels
- Target lesion involving the ostium of LAD, LCX, or RCA within 3 mm
- Target lesion located in a bypass graft artery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Affiliated Beijing Luhe Hospital of Capital Medical University
Beijin, Beijing Municipality, China, 101149
Not Yet Recruiting
2
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
Not Yet Recruiting
3
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 150000
Not Yet Recruiting
4
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
5
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, China, 150000
Not Yet Recruiting
6
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, China, 150000
Not Yet Recruiting
7
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
9
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430022
Not Yet Recruiting
10
The Third Second Hospital of Jilin University
Changchun, Jilin, China, 132000
Not Yet Recruiting
11
Dalian Municipal Central Hospital
Dalian, Liaoning, China, 116000
Not Yet Recruiting
12
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116000
Not Yet Recruiting
13
The People's Hospital of Liaoning Province
Shengyang, Liaoning, China, 132000
Not Yet Recruiting
14
The Affiliated Hospital of Neimenggu Medical University
Hohhot, Neimenggu, China, 011500
Not Yet Recruiting
15
Shandong Provincial Hospital
Jinan, Shandong, China, 250000
Not Yet Recruiting
16
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 250000
Not Yet Recruiting
17
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 250000
Not Yet Recruiting
18
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 250000
Not Yet Recruiting
Research Team
H
Haibo Jia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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