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

July 11, 2024 updated by: Yu Bo, Harbin Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Bo Yu
        • Principal Investigator:
          • Haibo Jia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Minimal lumen area (MLA)
Time Frame: At 12 months
OCT-MLA
At 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute change and percent change of MLA;
Time Frame: At 12 months
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);
Time Frame: At 12 months
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);
Time Frame: At 12 months
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;
Time Frame: At 12 months
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
Time Frame: At 12 months
At 12 months
Percentage of participants with FCT <65 μm;
Time Frame: At 12 months
At 12 months
Percentage of participants with PB >65%;
Time Frame: At 12 months
At 12 months
Percentage of participants with PB >70%;
Time Frame: At 12 months
At 12 months
Percentage of participants with MLA <3.5 mm2;
Time Frame: At 12 months
At 12 months
Percentage of participants with maximal lipid arc >180°;
Time Frame: At 12 months
At 12 months
Percentage of participants with positive remodeling;
Time Frame: At 12 months
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;
Time Frame: At 12 months
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;
Time Frame: At 12 months
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;
Time Frame: At 12 months
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;
Time Frame: At 12 months
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;
Time Frame: At 12 months
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;
Time Frame: At 12 months
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.
Time Frame: At 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Shenqi Medical Technology Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bo Yu, The Second Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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