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

NCT06365502 | Recruiting DMC

• 1 other identifier: KY2023-156
• Study Type: interventional
• Target: 1,860
• Locations: 1 country
• Sites: 18

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.

Conditions

Acute Coronary Syndrome (ACS)

Outcome Measures

Primary Outcomes (1)

• Target lesion failure (TLF)

  At 24 months

Secondary Outcomes (45)

• Target lesion failure (TLF)

  At 30 days

• Target lesion failure (TLF)

  At 6 months

• Target lesion failure (TLF)

  At 12 months

• Major cardiac adverse event (MACE)

  At 30 days

• Major cardiac adverse event (MACE)

  At 6 months

Study Arms (2)

DCB treatment

EXPERIMENTAL

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.

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

Guideline-directed medical treatment

ACTIVE COMPARATOR

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.

Drug: Guideline-directed medical treatment

Interventions

Drug-coated balloon DEVICE

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

DCB treatment

Guideline-directed medical treatment DRUG

All individuals will receive guideline-directed medical treatment.

DCB treatment; Guideline-directed medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)
• Hypotension, shock, or need for mechanical support or intravenous vasopressors;
• Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR)
• Left ventricular ejection fraction\<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
• Life expectancy \<2 years for any
• Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
• 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.
• The target lesion is located within 10 mm of the proximal or distal of stent
• The target lesion cannot be in the left main coronary artery
• The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is \>2 mm with \>50% of stenosis)
• The target lesion is located in severe calcification or tortuosity of vessels
• The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
• The target lesion is located within the bypass graft artery

Sponsors & Collaborators

• Harbin Medical University: lead
• Shanghai Shenqi Medical Technology Co., Ltd: collaborator

Study Sites (18)

Affiliated Beijing Luhe Hospital of Capital Medical University

Beijin, Beijing Municipality, 101149, China

NOT YET RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

NOT YET RECRUITING

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 150000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, 150000, China

NOT YET RECRUITING

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, 150000, China

NOT YET RECRUITING

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

The Third Second Hospital of Jilin University

Changchun, Jilin, 132000, China

NOT YET RECRUITING

Dalian Municipal Central Hospital

Dalian, Liaoning, 116000, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

NOT YET RECRUITING

The People's Hospital of Liaoning Province

Shengyang, Liaoning, 132000, China

NOT YET RECRUITING

The Affiliated Hospital of Neimenggu Medical University

Hohhot, Neimenggu, 011500, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250000, China

NOT YET RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 250000, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 250000, China

NOT YET RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 250000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bo Yu, PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibo Jia, PhD

CONTACT

15945685291; jhb101180@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiology Department, the 2nd Affiliated Hospital of Harbin Medical University

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

CN (18)