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

Harbin Medical University1,860 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,860

Conditions

Acute Coronary Syndrome (ACS)

Interventions

Drug-coated balloonDEVICE

Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.

Guideline-directed medical treatmentDRUG

All individuals will receive guideline-directed medical treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (18)

Affiliated Beijing Luhe Hospital of Capital Medical University

Beijin, Beijing Municipality, China

Outcomes

Primary Outcomes

Target lesion failure (TLF)

Time frame: At 24 months

Secondary Outcomes

Target lesion failure (TLF)

Time frame: At 30 days

Target lesion failure (TLF)

Time frame: At 6 months

Target lesion failure (TLF)

Time frame: At 12 months

Major cardiac adverse event (MACE)

MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

Time frame: At 30 days

Major cardiac adverse event (MACE)

MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

Time frame: At 6 months

Major cardiac adverse event (MACE)

MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

Time frame: At 12 months

Major cardiac adverse event (MACE)

MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

Time frame: At 24 months

All-cause death

Central Contacts

Haibo Jia, PhD

CONTACT

15945685291 jhb101180@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

NOT_YET_RECRUITING

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

NOT_YET_RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

NOT_YET_RECRUITING

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, China

NOT_YET_RECRUITING

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT_YET_RECRUITING

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

NOT_YET_RECRUITING

The Third Second Hospital of Jilin University

Changchun, Jilin, China

NOT_YET_RECRUITING

...and 8 more locations

Any death will be recorded as all-cause death

Time frame: At 30 days

All-cause death

Any death will be recorded as all-cause death

Time frame: At 6 months

All-cause death

Any death will be recorded as all-cause death

Time frame: At 12 months

All-cause death

Any death will be recorded as all-cause death

Time frame: At 24 months

Cardiac death and target lesion MI

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

Time frame: At 30 days

Cardiac death and target lesion MI

Time frame: At 6 months

Cardiac death and target lesion MI

Time frame: At 12 months

Cardiac death and target lesion MI

Time frame: At 24 months

Cardiac death

Time frame: At 30 days

Cardiac death

Time frame: At 6 months

Cardiac death

Time frame: At 12 months

Cardiac death

Time frame: At 24 months

Target lesion myocardial infarction

Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

Time frame: At 30 days

Target lesion myocardial infarction

Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

Time frame: At 6 months

Target lesion myocardial infarction

Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

Time frame: At 12 months

Target lesion myocardial infarction

Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

Time frame: At 24 months

Periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

Time frame: At 30 days

Periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

Time frame: At 6 months

Periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

Time frame: At 12 months

Periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

Time frame: At 24 months

Periprocedural and non-periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

Time frame: At 30 days

Periprocedural and non-periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

Time frame: At 6 months

Periprocedural and non-periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

Time frame: At 12 months

Periprocedural and non-periprocedural myocardial infarction

Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

Time frame: At 24 months

Target vessel failure (TVF)

TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

Time frame: At 30 days

Target vessel failure (TVF)

TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

Time frame: At 6 months

Target vessel failure (TVF)

TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

Time frame: At 12 months

Target vessel failure (TVF)

TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

Time frame: At 24 months

Minimal lumen area after DCB treatment