DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)

This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate Acute Lumen Gain after dilatation. A total of 200 patients will be enrolled from 4 sites in China. All patients enrolled will be randomly assigned to the test group (DK ScoreTM group, n=100) and the control group (NSE group, n=100) with randomized allocation ratio of 1:1. Patients in the test group and the control group will be treated with DK ScoreTM Scoring balloon catheters or NSE Coronary Dilatation Catheter. A 30-day after procedure follow-up will be conducted for all 200 patients.

Inclusion criteria

Patients related

• Age ≥ 18 years and ≤ 75 years.
• Patients with symptomatic coronary artery disease with stable and unstable angina pectoralis remote myocardial infarction , asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia.
• Patients with indications for coronary artery bypass grafting.
• Patients are able to follow protocol requirements and data collection procedures
• Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.

Lesions Related:

• Reference vessel diameter (RVD) between 2.0 and 4.0 mm by visual estimation.. Target lesion length ≤ 20 mm.
• More than 70% stenosis (or more than 50% stenosis combined with symptoms of ischemia). TIMI≥1.
• One target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The non-target lesion need be located at another coronary artery different from the target lesion.
• Investigator estimates that the target lesion need Cutting/Scoring balloon treatment. Target lesion is fully pre-dilated that scoring balloon is able to pass.

Exclusion criteria

Patients Related :

• AMI within 1 week.
• Patients has congestive heart failure or NYHA IV.
• Renal dysfunctional (CRE>443umol/L).
• Patient underwent heat transplant.
• Pregnant or nursing.
• Lifespan expectancy is less than 12 months
• Patients with history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency evaluated by investigator. Patients are forbidden to use anticoagulation agents or anti-platelet drugs.
• Patients are allergic to paclitaxel or heparin
• Difficult for evaluation or treatment.
• Patents are currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
• Patients participated in any other clinical trials less than 1 month.
• Interventional surgery is expected to be extremely risky unsuitable for study evaluated by investigator.
• Patient had poor compliance record and could not follow the study.

Lesion Related:

• Target Lesion located in Left Main Artery lesions and Ostial lesion within 5mm to Left Main Artery.
• Angiography shows thrombus in Target Lesion
• Chronic Total Occlusion Lesion