ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

Study Overview
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Brief Summary
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The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.

Detailed Description
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This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.

Official Title
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Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: test DCB
* Device: RESTORE DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length. Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months. Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form. Exclusion Criteria: AMI within 1 week. Subject has congestive heart failure or NYHA IV. Subject with LVEF < 35%. Subject has undergone heart transplantation. Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia. Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding. Subject with a history of leukopenia (white blood cell count of < 3×109/L for >3 days), neutropenia (ANC<1000/mm3 for >3 days) or thrombocytopenia (platelet <100,000/mm3). Known renal insufficiency (eGFR<30 ml/min). Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel. Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint. Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases. Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test DCB group<br>use the DCB made by Acotec Scientific | Device: test DCB<br>* use paclitaxel coated coronary balloon catheters to treat SVD<br>|
| Active Comparator: RESTORE DCB group<br>use the DCB made by CARDIONOVUM GmbH | Device: RESTORE DCB<br>* use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic percent diameter stenosis | (1-Segmental minimum lumen diameter [MLD]/ segmental reference vessel diameter [RVD]) ×100% | at 9 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute success | Including instrument success rate, lesion success rate and surgical success rate | in the procedure | 
| Rate of target lesion failure | A composite of cardiac death, target-vessel related myocardial infarction, and ischemia-driven target lesion revascularization | within 12 months post-procedure | 
| Diameter stenosis in-device | (1-the minimum cavity diameter of the device [MLD] / the reference vessel diameter of the device [RVD]) ×100% | at 9 months post-procedure | 
| Late lumen loss | Loss of late lumen in the segment and device | at 9 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary small vessel diseases, DCB