DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DK ScoreTM Coronary Scoring Balloon (DK Score) DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD |
Device: DK ScoreTM Coronary Scoring Balloon
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.
Other Names:
|
| Active Comparator: Non-Slip Element Coronary Dilatation Catheter (NSE) Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD |
Device: Non-Slip Element Coronary Dilatation Catheter
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Numerical Acute Lumen Gain in mm (QCA) [During the procedure]
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.
Secondary Outcome Measures
- Rate of Device success in percent [During the procedure]
Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.
- Rate of Target Lesion Failure in percent [30±7 Days]
Defined as any Target Lesion Failure after procedure
- Rate of Patient-oriented Composite Endpoint (POCE) in percent [30±7 Days]
Patient-oriented Composite Endpoint after procedure
- Rate of other Complications in percent [During the procedure]
Incidence of complications associated with the use of scoring balloon catheters
- Rate of Clinical Success in percent [During the procedure]
Defined as <20% diameter stenosis after stenting for DCB, without in-hospital major adverse cardiac events/MI/TLR After PCI
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients related
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Age ≥ 18 years and ≤ 75 years.
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Patients with symptomatic coronary artery disease with stable and unstable angina pectoralis remote myocardial infarction , asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia.
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Patients with indications for coronary artery bypass grafting.
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Patients are able to follow protocol requirements and data collection procedures
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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:
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Reference vessel diameter (RVD) between 2.0 and 4.0 mm by visual estimation.. Target lesion length ≤ 20 mm.
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More than 70% stenosis (or more than 50% stenosis combined with symptoms of ischemia). TIMI≥1.
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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.
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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 :
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AMI within 1 week.
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Patients has congestive heart failure or NYHA IV.
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Renal dysfunctional (CRE>443umol/L).
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Patient underwent heat transplant.
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Pregnant or nursing.
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Lifespan expectancy is less than 12 months
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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.
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Patients are allergic to paclitaxel or heparin
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Difficult for evaluation or treatment.
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Patents are currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
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Patients participated in any other clinical trials less than 1 month.
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Interventional surgery is expected to be extremely risky unsuitable for study evaluated by investigator.
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Patient had poor compliance record and could not follow the study.
Lesion Related:
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Target Lesion located in Left Main Artery lesions and Ostial lesion within 5mm to Left Main Artery.
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Angiography shows thrombus in Target Lesion
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Chronic Total Occlusion Lesion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anzhen Hospital affiliated to Capital University of Medical | Beijing | Beijing | China | |
| 2 | Xuzhou Third People Hospital | Xuzhou | Jiangsu | China | |
| 3 | Taiyuan Central Hospital | Taiyuan | Shanxi | China | |
| 4 | Tianjin Chest Hospita | Tianjin | Tianjin | China |
Sponsors and Collaborators
- DK Medical Technology (Suzhou) Co., Ltd.
Investigators
- Principal Investigator: Yujie Zhou, Dr., Beijing Anzhen Hospital affiliated to Capital University of Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VP-P-2019-006