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

Harbin Medical University

Status: Enrolling

Conditions: Acute Coronary Syndrome (ACS)

Treatments: Device: Drug-coated balloon; Drug: Guideline-directed medical treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06365502

KY2023-156

Details and patient eligibility

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.

Enrollment: 1,860 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,860 participants in 2 patient groups

DCB treatment

Experimental group

Description:

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.

Treatment:

Drug: Guideline-directed medical treatment

Device: Drug-coated balloon

Guideline-directed medical treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Guideline-directed medical treatment