Status:
COMPLETED
DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
Lead Sponsor:
DK Medical Technology (Suzhou) Co., Ltd.
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18-75 years
Phase:
NA
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 cor...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05250193
Start Date
March 24 2021
End Date
December 30 2021
Last Update
March 10 2022
Active Locations (4)
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1
Beijing Anzhen Hospital affiliated to Capital University of Medical
Beijing, Beijing Municipality, China
2
Xuzhou Third People Hospital
Xuzhou, Jiangsu, China
3
Taiyuan Central Hospital
Taiyuan, Shanxi, China
4
Tianjin Chest Hospita
Tianjin, Tianjin Municipality, China