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

Launched by DK MEDICAL TECHNOLOGY (SUZHOU) CO., LTD. · Feb 17, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients related
• • 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:
• Patients Related :
• • 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