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

Last updated: July 11, 2024
Sponsor: Harbin Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Angina

Coronary Artery Disease

Chest Pain

Treatment

Drug-coated balloon

Guideline-directed medical treatment

Clinical Study ID

NCT06449274
KY2023-156-1
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 forPCI

  3. Successful stent implantation (i.e., residual stenosis less than 20%) must be donein culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or lessthan 0.8)

  4. Subject must have at least one native non-culprit lesion with visually estimatedstenosis 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

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 studydevices, including paclitaxel, etc) that cannot be adequately pre-medicated

  2. Subject is receiving immunosuppressant therapy or has known immunosuppressive orsevere 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 forestimated GFR)

  5. Left ventricular ejection fraction<30% by the most recent imaging test within 30days 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 deviceclinical study that has not yet completed its primary endpoint

  8. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation 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 thebranch 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 theostium)

  14. The target lesion is located within the bypass graft artery

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Drug-coated balloon
Phase:
Study Start date:
June 25, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.