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

Acute Coronary Syndrome (ACS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365502
• Other study ID #: KY2023-156
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: December 2030

Study information

• Verified date: May 2024
• Source: Harbin Medical University
• Contact: Haibo Jia, PhD
• Phone: 15945685291
• Email: jhb101180[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1860
• Est. completion date: December 2030
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Plaque, Atherosclerotic

Intervention

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

Country	Name	City	State
China	Affiliated Beijing Luhe Hospital of Capital Medical University	Beijin	Beijing
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	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Affiliated Hospital of Neimenggu Medical University	Hohhot	Neimenggu
China	The First Affiliated Hospital of Jiamusi University	Jiamusi	Heilongjiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Mudanjiang Cardiovascular Hospital	Mudanjiang	Heilongjiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	The People's Hospital of Liaoning Province	Shengyang	Liaoning
China	Tongji Hospital Tongji Medical College of HUST	Wuhan	Hubei
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
Harbin Medical University	Shanghai Shenqi Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure (TLF)		At 24 months
Secondary	Target lesion failure (TLF)		At 30 days
Secondary	Target lesion failure (TLF)		At 6 months
Secondary	Target lesion failure (TLF)		At 12 months
Secondary	Major cardiac adverse event (MACE)	MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina	At 30 days
Secondary	Major cardiac adverse event (MACE)	MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina	At 6 months
Secondary	Major cardiac adverse event (MACE)	MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina	At 12 months
Secondary	Major cardiac adverse event (MACE)	MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina	At 24 months
Secondary	All-cause death	Any death will be recorded as all-cause death	At 30 days
Secondary	All-cause death	Any death will be recorded as all-cause death	At 6 months
Secondary	All-cause death	Any death will be recorded as all-cause death	At 12 months
Secondary	All-cause death	Any death will be recorded as all-cause death	At 24 months
Secondary	Cardiac death and target lesion MI	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 30 days
Secondary	Cardiac death and target lesion MI	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 6 months
Secondary	Cardiac death and target lesion MI	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 12 months
Secondary	Cardiac death and target lesion MI	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 24 months
Secondary	Cardiac death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 30 days
Secondary	Cardiac death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 6 months
Secondary	Cardiac death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 12 months
Secondary	Cardiac death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment	At 24 months
Secondary	Target lesion myocardial infarction	Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed	At 30 days
Secondary	Target lesion myocardial infarction	Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed	At 6 months
Secondary	Target lesion myocardial infarction	Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed	At 12 months
Secondary	Target lesion myocardial infarction	Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed	At 24 months
Secondary	Periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.	At 30 days
Secondary	Periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.	At 6 months
Secondary	Periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.	At 12 months
Secondary	Periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.	At 24 months
Secondary	Periprocedural and non-periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed	At 30 days
Secondary	Periprocedural and non-periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed	At 6 months
Secondary	Periprocedural and non-periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed	At 12 months
Secondary	Periprocedural and non-periprocedural myocardial infarction	Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed	At 24 months
Secondary	Target vessel failure (TVF)	TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.	At 30 days
Secondary	Target vessel failure (TVF)	TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.	At 6 months
Secondary	Target vessel failure (TVF)	TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.	At 12 months
Secondary	Target vessel failure (TVF)	TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.	At 24 months
Secondary	Minimal lumen area after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	Plaque burden after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	FCT after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	Lipid arc after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	FCT <75 µm after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	PB >65% after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	PB >70% after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	MLA <3.5 mm^2 after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	Maximal lipid arc >180° after DCB treatment	Post-procedure imaging examination is required	At baseline
Secondary	Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1ß and ceramide etc.	The centers with sample preservation qualifications will be asked to preserve blood samples.	At baseline and one-year follow-up