Clinical trial NCT06365502: Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Official title: A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome (ACS)
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai Shenqi Medical Technology Co., Ltd
First posted: 2024-04-15
Enrollment: 1860
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Target lesion failure (TLF)
timeFrame: At 24 months
Secondary outcomes:
measure: Target lesion failure (TLF)
timeFrame: At 30 days
measure: Target lesion failure (TLF)
timeFrame: At 6 months
measure: Target lesion failure (TLF)
timeFrame: At 12 months
measure: Major cardiac adverse event (MACE)
timeFrame: At 30 days
measure: Major cardiac adverse event (MACE)
timeFrame: At 6 months
measure: Major cardiac adverse event (MACE)
timeFrame: At 12 months
measure: Major cardiac adverse event (MACE)
timeFrame: At 24 months
measure: All-cause death
timeFrame: At 30 days
measure: All-cause death
timeFrame: At 6 months
measure: All-cause death
timeFrame: At 12 months
measure: All-cause death
timeFrame: At 24 months
measure: Cardiac death and target lesion MI
timeFrame: At 30 days
measure: Cardiac death and target lesion MI
timeFrame: At 6 months
measure: Cardiac death and target lesion MI
timeFrame: At 12 months
measure: Cardiac death and target lesion MI
timeFrame: At 24 months
measure: Cardiac death
timeFrame: At 30 days
measure: Cardiac death
timeFrame: At 6 months
measure: Cardiac death
timeFrame: At 12 months
measure: Cardiac death
timeFrame: At 24 months
measure: Target lesion myocardial infarction
timeFrame: At 30 days
measure: Target lesion myocardial infarction
timeFrame: At 6 months
measure: Target lesion myocardial infarction
timeFrame: At 12 months
measure: Target lesion myocardial infarction
timeFrame: At 24 months
measure: Periprocedural myocardial infarction
timeFrame: At 30 days
measure: Periprocedural myocardial infarction
timeFrame: At 6 months
measure: Periprocedural myocardial infarction
timeFrame: At 12 months
measure: Periprocedural myocardial infarction
timeFrame: At 24 months
measure: Periprocedural and non-periprocedural myocardial infarction
timeFrame: At 30 days
measure: Periprocedural and non-periprocedural myocardial infarction
timeFrame: At 6 months
measure: Periprocedural and non-periprocedural myocardial infarction
timeFrame: At 12 months
measure: Periprocedural and non-periprocedural myocardial infarction
timeFrame: At 24 months
measure: Target vessel failure (TVF)
timeFrame: At 30 days
measure: Target vessel failure (TVF)
timeFrame: At 6 months
measure: Target vessel failure (TVF)
timeFrame: At 12 months
measure: Target vessel failure (TVF)
timeFrame: At 24 months
measure: Minimal lumen area after DCB treatment
timeFrame: At baseline
measure: Plaque burden after DCB treatment
timeFrame: At baseline
measure: FCT after DCB treatment
timeFrame: At baseline
measure: Lipid arc after DCB treatment
timeFrame: At baseline
measure: FCT <75 μm after DCB treatment
timeFrame: At baseline
measure: PB >65% after DCB treatment
timeFrame: At baseline
measure: PB >70% after DCB treatment
timeFrame: At baseline
measure: MLA <3.5 mm^2 after DCB treatment
timeFrame: At baseline
measure: Maximal lipid arc >180° after DCB treatment
timeFrame: At baseline
measure: Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc.
timeFrame: At baseline and one-year follow-up
Other outcomes:
Locations:
city: Beijin
country: China
facility: Affiliated Beijing Luhe Hospital of Capital Medical University
state: Beijing
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Jiamusi
country: China
facility: The First Affiliated Hospital of Jiamusi University
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang Cardiovascular Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST
state: Hubei
city: Changchun
country: China
facility: The Third Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shengyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Hohhot
country: China
facility: The Affiliated Hospital of Neimenggu Medical University
state: Neimenggu
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: