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Acute Coronary Syndrome (ACS)NCT06449274

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

A study testing Drug-coated balloon and Guideline-directed medical treatment in people with Acute Coronary Syndrome (ACS), run by Harbin Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Coronary Syndrome (ACS)
What is being tested?
Drug-coated balloon and Guideline-directed medical treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
25 Jun 2024to Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Haibo Jia contact

15945685291

jhb101180@163.com

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    Haibo Jia, 15945685291, jhb101180@163.com

    Bo Yu

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Drug-coated balloon, Guideline-directed medical treatment
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug-coated balloonDevice

    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.

  • Guideline-directed medical treatmentDrug

    All individuals will receive guideline-directed medical treatment.

Study groups in NCT06449274
Study groupRoleWhat they receive
DCB treatmentExperimentalNon-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.
Receives: Device: Drug-coated balloon; Drug: Guideline-directed medical treatment
Guideline-directed medical treatmentActive comparatorNon-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.
Receives: Drug: Guideline-directed medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimal lumen area (MLA)

    OCT-MLA

    Measured: At 12 months

Secondary outcomes (18)

  1. 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.

    Measured: At 12 months

  2. 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.

    Measured: At 12 months

  3. 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.

    Measured: At 12 months

  4. 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.

    Measured: At 12 months

  5. Percentage of participants with FCT <75 μm

    Measured: At 12 months

  6. Percentage of participants with FCT <65 μm;

    Measured: At 12 months

  7. Percentage of participants with PB >65%;

    Measured: At 12 months

  8. Percentage of participants with PB >70%;

    Measured: At 12 months

  9. Percentage of participants with MLA <3.5 mm2;

    Measured: At 12 months

  10. Percentage of participants with maximal lipid arc >180°;

    Measured: At 12 months

  11. 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.

    Measured: At 12 months

  12. Percentage of participants with macrophages;

    Macrophage will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.

    Measured: At 12 months

  13. Percentage of participants with lipid plaques;

    Lipid plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.

    Measured: At 12 months

  14. Percentage of participants with microchannels;

    Microchannels will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.

    Measured: At 12 months

  15. Percentage of participants with cholesterol crystal;

    Cholesterol crystal will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.

    Measured: At 12 months

  16. Percentage of participants with calcification;

    Calcification will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.

    Measured: At 12 months

  17. Percentage of participants with healed plaque;

    Healed plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.

    Measured: At 12 months

  18. 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.

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start25 Jun 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449274
Sponsor's protocol ID
KY2023-156-1
Status last verified
Jul 2024
First submitted
10 Apr 2024
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Drug-coated balloon and Guideline-directed medical treatment in people with Acute Coronary Syndrome (ACS), run by Harbin Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haibo Jia (15945685291, jhb101180@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal lumen area (MLA) (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06449274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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