Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06449274

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

Led by Harbin Medical University · Updated on 2024-07-15

180

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

H

Harbin Medical University

Lead Sponsor

S

Shanghai Shenqi Medical Technology Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Acute myocardial infarction or unstable angina planned for PCI
  • Successful stent implantation with residual stenosis less than 20% in culprit and ischemic lesions
  • At least one native non-culprit lesion with 40-80% stenosis and QFR >0.8
  • Target lesion diameter between 2.0 and 4.0 mm and length ≤ 50 mm
  • Target lesion meets at least two intravascular imaging criteria: plaque burden >65%, minimal lumen area <3.5 mm² (OCT) or <4.0 mm² (IVUS), fibrous cap thickness <75 µm, or maximal lipid arc >180°
  • Written informed consent provided before any study-related procedure
Not Eligible

You will not qualify if you...

  • Known allergy or contraindication to study drugs including aspirin, P2Y12 inhibitors, paclitaxel, or device components not manageable with pre-medication
  • Receiving immunosuppressants or having severe autoimmune diseases requiring chronic immunosuppressive therapy
  • Hypotension, shock, or need for mechanical support or intravenous vasopressors
  • Creatinine clearance ≤30 ml/min/1.73 m²
  • Left ventricular ejection fraction <30% within 30 days before procedure
  • Life expectancy less than 2 years
  • Current participation in another investigational drug or device study with incomplete primary endpoint
  • Other anatomical, medical, social, or psychological conditions limiting participation or compliance
  • Target lesion within 10 mm of proximal or distal stent
  • Target lesion located in the left main coronary artery
  • Target lesion in a bifurcation lesion with branch diameter >2 mm and >50% stenosis
  • Target lesion in severely calcified or tortuous vessels
  • Target lesion involving ostium of LAD, LCX, or RCA within 3 mm
  • Target lesion located in bypass graft artery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150000

Actively Recruiting

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Research Team

H

Haibo Jia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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