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

Acute Coronary Syndrome (ACS) Clinical Trial

Official title:

Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque: an OCT-IVUS Imaging Substudy (RESTORE Imaging)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449274
• Other study ID #: KY2023-156-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• 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)

Intervention

Device:
• Drug-coated balloon
Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed. Individual will receive guideline-directed medical treatment.

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

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	Minimal lumen area (MLA)	OCT-MLA	At 12 months
Secondary	Absolute change and percent change of MLA;	Absolute change of MLA (mm2) is defined as the difference between baseline and follow-up MLA in OCT imaging. Percent change of MLA (%) is defined as absolute change of MLA divided by baseline MLA.	At 12 months
Secondary	Absolute change and percent change of maximum plaque burden (PB);	Absolute change of maximum PB (%) is defined as the difference between baseline and follow-up PB in IVUS imaging. Percent change of plaque burden (%) is defined as absolute change of PB divided by baseline PB.	At 12 months
Secondary	Absolute change and percent change of fibrous cap thickness (FCT);	Absolute change of FCT (µm) is defined as the difference between baseline and follow-up FCT in OCT imaging. Percent change of FCT (%) is defined as absolute change of FCT divided by baseline FCT.	At 12 months
Secondary	Absolute change and percent change of maximum lipid arc;	Absolute change of maximum lipid arc (°) is defined as the difference between baseline and follow-up maximum lipid arc in OCT imaging. Percent change of maximum lipid arc (%) is defined as absolute change of maximum lipid arc divided by baseline maximum lipid arc.	At 12 months
Secondary	Percentage of participants with FCT <75 µm		At 12 months
Secondary	Percentage of participants with FCT <65 µm;		At 12 months
Secondary	Percentage of participants with PB >65%;		At 12 months
Secondary	Percentage of participants with PB >70%;		At 12 months
Secondary	Percentage of participants with MLA <3.5 mm2;		At 12 months
Secondary	Percentage of participants with maximal lipid arc >180°;		At 12 months
Secondary	Percentage of participants with positive remodeling;	Positive remodeling is defined as Remodeling index (cross sectional area (CSA) of external elastic membrane (EEM) in lesion divided by CSA of EEM in reference vessel) >1.05.	At 12 months
Secondary	Percentage of participants with macrophages;	Macrophage will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Secondary	Percentage of participants with lipid plaques;	Lipid plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Secondary	Percentage of participants with microchannels;	Microchannels will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Secondary	Percentage of participants with cholesterol crystal;	Cholesterol crystal will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Secondary	Percentage of participants with calcification;	Calcification will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Secondary	Percentage of participants with healed plaque;	Healed plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months
Secondary	Percentage of participants with non-culprit plaque rupture.	Non-culprit plaque rupture will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.	At 12 months