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Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

NCT06365502 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1860

Last updated 2024-05-22

No results posted yet for this study

Summary

The objective of this multicenter, prospective, open-label, controlled, randomized 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 clinical cardiovascular outcomes in patients with acute coronary syndrome.

Conditions

  • Acute Coronary Syndrome (ACS)

Interventions

DEVICE

Drug-coated balloon

Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.

DRUG

Guideline-directed medical treatment

All individuals will receive guideline-directed medical treatment.

Sponsors & Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

    collaborator INDUSTRY

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Bo Yu, PhD · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365502 on ClinicalTrials.gov