DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
NCT ID: NCT05250193
Last Updated: 2022-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2021-03-24
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DK ScoreTM Coronary Scoring Balloon (DK Score)
DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD
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.
Non-Slip Element Coronary Dilatation Catheter (NSE)
Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 18 years and ≤ 75 years.
2. Patients with symptomatic coronary artery disease with stable and unstable angina pectoralis remote myocardial infarction , asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia.
3. Patients with indications for coronary artery bypass grafting.
4. Patients are able to follow protocol requirements and data collection procedures
5. 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:
1. Reference vessel diameter (RVD) between 2.0 and 4.0 mm by visual estimation.. Target lesion length ≤ 20 mm.
2. More than 70% stenosis (or more than 50% stenosis combined with symptoms of ischemia). TIMI≥1.
3. 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.
4. 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
1. AMI within 1 week.
2. Patients has congestive heart failure or NYHA IV.
3. Renal dysfunctional (CRE\>443umol/L).
4. Patient underwent heat transplant.
5. Pregnant or nursing.
6. Lifespan expectancy is less than 12 months
7. 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.
8. Patients are allergic to paclitaxel or heparin
9. Difficult for evaluation or treatment.
10. Patents are currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
11. Patients participated in any other clinical trials less than 1 month.
12. Interventional surgery is expected to be extremely risky unsuitable for study evaluated by investigator.
13. Patient had poor compliance record and could not follow the study.
Lesion Related:
1. Target Lesion located in Left Main Artery lesions and Ostial lesion within 5mm to Left Main Artery.
2. Angiography shows thrombus in Target Lesion
3. Chronic Total Occlusion Lesion
18 Years
75 Years
ALL
No
Sponsors
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DK Medical Technology (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yujie Zhou, Dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital affiliated to Capital University of Medical
Locations
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Beijing Anzhen Hospital affiliated to Capital University of Medical
Beijing, Beijing Municipality, China
Xuzhou Third People Hospital
Xuzhou, Jiangsu, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Tianjin Chest Hospita
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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VP-P-2019-006
Identifier Type: -
Identifier Source: org_study_id
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