RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial

Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque: an OCT-IVUS Imaging Substudy (RESTORE Imaging)

The objective of this imaging substudy of RESTORE 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 plaque stabilization in patients with acute coronary syndrome.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome (ACS)
• Intervention / Treatment: Drug: Guideline-directed medical treatment; Device: Drug-coated balloon

Detailed Description

The present study is an integrated imaging substudy of randomized, controlled and intervention trial of preventive drug-coated balloon angioplasty in vulnerable atherosclerotic plaque (RESTORE). The RESTORE Imaging trial will equally enroll from the DCB arm and GDMT arm to at least 180 consecutive individuals to validate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in enlarge luminal dimensions.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haibo Jia; Phone Number: 15945685291; Email: jhb101180@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: Haibo Jia; Phone Number: 15945685291; Email: jhb101180@163.com
      • Principal Investigator: Bo Yu
      • Principal Investigator: Haibo Jia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB 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.	Drug: Guideline-directed medical treatment; All individuals will receive guideline-directed medical treatment.; Device: Drug-coated balloon; Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed. Individual will receive guideline-directed medical treatment.
Active Comparator: 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.	Drug: Guideline-directed medical treatment; All individuals will receive guideline-directed medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal lumen area (MLA)	OCT-MLA	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change and percent change of MLA;	Absolute change of MLA (mm2) is defined as the difference between baseline and follow-up MLA in OCT imaging. Percent change of MLA (%) is defined as absolute change of MLA divided by baseline MLA.	At 12 months
Absolute change and percent change of maximum plaque burden (PB);	Absolute change of maximum PB (%) is defined as the difference between baseline and follow-up PB in IVUS imaging. Percent change of plaque burden (%) is defined as absolute change of PB divided by baseline PB.	At 12 months
Absolute change and percent change of fibrous cap thickness (FCT);	Absolute change of FCT (μm) is defined as the difference between baseline and follow-up FCT in OCT imaging. Percent change of FCT (%) is defined as absolute change of FCT divided by baseline FCT.	At 12 months
Absolute change and percent change of maximum lipid arc;	Absolute change of maximum lipid arc (°) is defined as the difference between baseline and follow-up maximum lipid arc in OCT imaging. Percent change of maximum lipid arc (%) is defined as absolute change of maximum lipid arc divided by baseline maximum lipid arc.	At 12 months
Percentage of participants with FCT <75 μm		At 12 months
Percentage of participants with FCT <65 μm;		At 12 months
Percentage of participants with PB >65%;		At 12 months
Percentage of participants with PB >70%;		At 12 months
Percentage of participants with MLA <3.5 mm2;		At 12 months
Percentage of participants with maximal lipid arc >180°;		At 12 months
Percentage of participants with positive remodeling;	Positive remodeling is defined as Remodeling index (cross sectional area (CSA) of external elastic membrane (EEM) in lesion divided by CSA of EEM in reference vessel) >1.05.	At 12 months
Percentage of participants with macrophages;	Macrophage will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Percentage of participants with lipid plaques;	Lipid plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Percentage of participants with microchannels;	Microchannels will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Percentage of participants with cholesterol crystal;	Cholesterol crystal will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Percentage of participants with calcification;	Calcification will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Percentage of participants with healed plaque;	Healed plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Percentage of participants with non-culprit plaque rupture.	Non-culprit plaque rupture will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: Shanghai Shenqi Medical Technology Co., Ltd
• Investigators: Principal Investigator: Bo Yu, The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: KY2023-156-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No