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Clinical Trials in China / NCT06365502
Recruiting Not applicable

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

NCT06365502 · tracked via the Priya Life Science China tracker
Sponsor
Harbin Medical University
Phase
Not applicable
Started
2024-04-16
Last updated
2024-05-22

Condition(s) studied

Acute Coronary Syndrome (ACS)

Investigational drug(s) / intervention(s)

Drug-coated balloonGuideline-directed medical treatment

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

Guideline-directed medical treatment: All individuals will receive guideline-directed medical treatment.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 for PCI 3. 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) 4. Subject must have at least one native non-culprit lesion with visually estimated stenosis 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 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 study devices, including paclitaxel, etc) that cannot be adequately pre-medicated 2. 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.) 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 for estimated GFR) 5. Left ventricular ejection fraction\<30% by the most recent imaging test within 30 days 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 device clinical study that has not yet completed its primary endpoint 8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation 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 the branch 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 the ostium) 14. The target lesion is located within the bypass graft artery

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Affiliated Beijing Luhe Hospital of Capital Medical University Beijin Beijing Municipality Not Yet Recruiting
Affiliated Hospital of Zunyi Medical University Zunyi Guizhou Not Yet Recruiting
Daqing Oilfield General Hospital Daqing Heilongjiang Not Yet Recruiting
The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Jiamusi University Jiamusi Heilongjiang Not Yet Recruiting
Mudanjiang Cardiovascular Hospital Mudanjiang Heilongjiang Not Yet Recruiting
Fuwai Central China Cardiovascular Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Tongji Hospital Tongji Medical College of HUST Wuhan Hubei Not Yet Recruiting
The Third Second Hospital of Jilin University Changchun Jilin Not Yet Recruiting
Dalian Municipal Central Hospital Dalian Liaoning Not Yet Recruiting
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning Not Yet Recruiting
The People's Hospital of Liaoning Province Shengyang Liaoning Not Yet Recruiting
The Affiliated Hospital of Neimenggu Medical University Hohhot Neimenggu Not Yet Recruiting
Shandong Provincial Hospital Jinan Shandong Not Yet Recruiting
Affiliated Hospital of Jining Medical University Jining Shandong Not Yet Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Not Yet Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Not Yet Recruiting

More Harbin Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06365502 on ClinicalTrials.gov ↗ ← All trials in China