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

ConditionAcute Coronary Syndrome (ACS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHarbin Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 m² (as calculated by MDRD formula for estimated GFR)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug-coated balloon

    Device

    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 treatment

    Drug

    All individuals will receive guideline-directed medical treatment.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: DCB treatmentExperimental treatment 2 interventions
Group B: Guideline-directed medical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Minimal lumen area (MLA)

OCT-MLA

Time frame
At 12 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
At 12 months

Other outcomes

Sponsors and contacts

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Harbin Medical University

Lead sponsor

Shanghai Shenqi Medical Technology Co., Ltd

Collaborator

Source ClinicalTrials.gov
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