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RECRUITING
NCT06365502
NA

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

Sponsor: Harbin Medical University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1860

Start Date

2024-04-16

Completion Date

2030-12

Last Updated

2024-05-22

Healthy Volunteers

No

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.

Locations (18)

Affiliated Beijing Luhe Hospital of Capital Medical University

Beijin, Beijing Municipality, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

The Third Second Hospital of Jilin University

Changchun, Jilin, China

Dalian Municipal Central Hospital

Dalian, Liaoning, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The People's Hospital of Liaoning Province

Shengyang, Liaoning, China

The Affiliated Hospital of Neimenggu Medical University

Hohhot, Neimenggu, China

Shandong Provincial Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China