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

Not Applicable

Completed

• Conditions: Coronary Stenosis
• Interventions: Device: Non-Slip Element Coronary Dilatation Catheter; Device: DK ScoreTM Coronary Scoring Balloon

• Registration Number: NCT05250193
• Lead Sponsor: DK Medical Technology (Suzhou) Co., Ltd.

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.

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 Timeline

• Study Start: 2021-03-24
• Primary Completion: 2021-09-02
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-22
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Slip Element Coronary Dilatation Catheter (NSE)	Non-Slip Element Coronary Dilatation Catheter	Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD
DK ScoreTM Coronary Scoring Balloon (DK Score)	DK ScoreTM Coronary Scoring Balloon	DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of Target Lesion Failure in percent	30±7 Days	Defined as any Target Lesion Failure after procedure
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
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 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

Trial Locations

Locations (4)

Beijing Anzhen Hospital affiliated to Capital University of Medical; 🇨🇳 Beijing, Beijing, China

Xuzhou Third People Hospital; 🇨🇳 Xuzhou, Jiangsu, China

Taiyuan Central Hospital; 🇨🇳 Taiyuan, Shanxi, China

Tianjin Chest Hospita; 🇨🇳 Tianjin, Tianjin, China