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

Study Overview
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Brief Summary
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A prospective, Multi-center, Randomized Study designed to evaluate the acute lumen gain and device procedural success of the DK ScoreTM Scoring balloon versus NSE Scoring Balloon for patients with coronary arteries stenosis.

Detailed Description
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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.

Official Title
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A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of DK ScoreTM Scoring Balloon Vesus Non-Slip Element Coronary Dilatation Catheter for Coronary Artery Stenosis

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Device: DK ScoreTM Coronary Scoring Balloon
* Device: Non-Slip Element Coronary Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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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

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DK ScoreTM Coronary Scoring Balloon (DK Score)<br>DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD | Device: DK ScoreTM Coronary Scoring Balloon<br>* After pre-dilation balloon is used (if any), DK Score is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.<br>* Other names: DK Score;|
| Active Comparator: Non-Slip Element Coronary Dilatation Catheter (NSE)<br>Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD | Device: Non-Slip Element Coronary Dilatation Catheter<br>* After pre-dilation balloon is used (if any), NSE is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.<br>* Other names: NSE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Acute Lumen Gain in mm (QCA) | Acute Lumen Gain for both arms will be measure with QCA, as accessed by independent core-lab. Angiographic endpoint will be in-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Device success in percent | Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure. | During the procedure | 
| Rate of Target Lesion Failure in percent | Defined as any Target Lesion Failure after procedure | 30±7 Days | 
| Rate of Patient-oriented Composite Endpoint (POCE) in percent | Patient-oriented Composite Endpoint after procedure | 30±7 Days | 
| Rate of other Complications in percent | Incidence of complications associated with the use of scoring balloon catheters | During the procedure | 
| Rate of Clinical Success in percent | Defined as <20% diameter stenosis after stenting for DCB, without in-hospital major adverse cardiac events/MI/TLR After PCI | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoring balloon; DK Score; NSE