Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease

Study Overview
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Brief Summary
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The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

Detailed Description
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The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA. After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention. Subjects will be followed through hospital discharge.

Official Title
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A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease

Conditions
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Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis

Intervention / Treatment
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* Device: SINOMED CBC
* Device: NSE Coronary Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is at least 18 to 75 years of age, male or not pregnant female. Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis. Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm. Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia. The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels. Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent. Exclusion Criteria: Evidence of ongoing acute myocardial infarction within a week. Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion. Severe calcification and Target lesion in a severe angulation (> 45 degrees). Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%. Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl. Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation. Patients with allergies to heparin and contrast media. Target lesion demonstrating severe dissection prior to planned deployment of the trial device. Visible thrombus at the target lesion. Patients received heart transplantation. Participation in another clinical trial (12 months after index procedure). Those who participated in another clinical trials, but did not reach the primary endpoint.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: A prospective, multicenter, randomized control,non-inferiority clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SINOMED CBC<br>Cutting balloon catheter (Sino Medical Sciences Technology Inc.) | Device: SINOMED CBC<br>* The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.<br>* Other names: scoring balloon catheter;|
| Active Comparator: NSE Coronary Dilatation Catheter<br>NSE Coronary Dilatation Catheter (Goodman Co.,Ltd) | Device: NSE Coronary Dilatation Catheter<br>* The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.<br>* Other names: Lacrosse NSE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Device procedural success (lesion level) | Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%) | immediate post-intervention(approximately 1.4 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Procedural success (patient level) | Defined as: ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%); and freedom from major adverse cardiac events (MACE) during hospitalization | during the hospital stay, an average of 7 days post-procedure | 
| Rate of Target lesion failure (TLF) | a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR) | during the hospital stay, an average of 7 days post-procedure | 
| Rate of Patient-oriented composite endpoint (POCE) | a composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization | during the hospital stay, an average of 7 days post-procedure | 
| Incidence of any AE and SAE incidence | report any AE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst、vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on. | during the hospital stay, an average of 7 days post-procedure | 
| Rate of device defect | report any device defect during hospitalization | during the hospital stay, an average of 7 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scoring balloon catheter, Coronary dilation catheter, Percutaneous coronary artery dilatation, Restenosis, Cutting balloon catheter