Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome (ACS)
• Interventions: Device: Drug-coated balloon; Drug: Guideline-directed medical treatment

• Registration Number: NCT06365502
• Lead Sponsor: Harbin Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Study Start: 2024-04-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2027-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1860

Inclusion Criteria

1. Subjects must be between 18 and 80 years of age
2. Subject must present with acute myocardial infarction or unstable angina planned for PCI
3. 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)
4. Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
5. Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
6. 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°
7. Subject must provide written informed consent before any study-related procedure

Exclusion Criteria

1. Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
2. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
3. Hypotension, shock, or need for mechanical support or intravenous vasopressors;
4. Creatinine clearance ≤30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR)
5. Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
6. Life expectancy <2 years for any
7. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
9. The target lesion is located within 10 mm of the proximal or distal of stent
10. The target lesion cannot be in the left main coronary artery
11. The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
12. The target lesion is located in severe calcification or tortuosity of vessels
13. The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
14. The target lesion is located within the bypass graft artery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCB treatment	Drug-coated balloon	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.
Guideline-directed medical treatment	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.
DCB treatment	Guideline-directed medical 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.

Primary Outcome Measures

Name	Time	Method
Target lesion failure (TLF)	At 24 months

Secondary Outcome Measures

Name	Time	Method
Plaque burden after DCB treatment	At baseline	Post-procedure imaging examination is required
Cardiac death and target lesion MI	At 24 months	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Minimal lumen area after DCB treatment	At baseline	Post-procedure imaging examination is required
PB >70% after DCB treatment	At baseline	Post-procedure imaging examination is required
Target lesion failure (TLF)	At 12 months
Major cardiac adverse event (MACE)	At 24 months	MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina
All-cause death	At 24 months	Any death will be recorded as all-cause death
Cardiac death	At 24 months	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Target lesion myocardial infarction	At 24 months	Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed
Periprocedural myocardial infarction	At 24 months	Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.
Periprocedural and non-periprocedural myocardial infarction	At 24 months	Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed
Target vessel failure (TVF)	At 24 months	TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.
FCT after DCB treatment	At baseline	Post-procedure imaging examination is required
PB >65% after DCB treatment	At baseline	Post-procedure imaging examination is required
Lipid arc after DCB treatment	At baseline	Post-procedure imaging examination is required
FCT <75 μm after DCB treatment	At baseline	Post-procedure imaging examination is required
MLA <3.5 mm^2 after DCB treatment	At baseline	Post-procedure imaging examination is required
Maximal lipid arc >180° after DCB treatment	At baseline	Post-procedure imaging examination is required
Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc.	At baseline and one-year follow-up	The centers with sample preservation qualifications will be asked to preserve blood samples.

Trial Locations

Locations (18)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, 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 Affiliated Hospital of Neimenggu Medical University; 🇨🇳 Hohhot, Neimenggu, China

Affiliated Hospital of Jining Medical University; 🇨🇳 Jining, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Fuwai Central China Cardiovascular Hospital; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Tongji Medical College of HUST; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Jiamusi University; 🇨🇳 Jiamusi, Heilongjiang, China

Affiliated Beijing Luhe Hospital of Capital Medical University; 🇨🇳 Beijin, Beijing, China

Mudanjiang Cardiovascular Hospital; 🇨🇳 Mudanjiang, Heilongjiang, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

The People's Hospital of Liaoning Province; 🇨🇳 Shengyang, Liaoning, China

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China