Clinical trial NCT05250193: DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
Official title: A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of DK ScoreTM Scoring Balloon Vesus Non-Slip Element Coronary Dilatation Catheter for Coronary Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenosis
Keywords: Scoring balloon; DK Score; NSE
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numerical Acute Lumen Gain in mm (QCA)
timeFrame: During the procedure
Secondary outcomes:
measure: Rate of Device success in percent
timeFrame: During the procedure
measure: Rate of Target Lesion Failure in percent
timeFrame: 30±7 Days
measure: Rate of Patient-oriented Composite Endpoint (POCE) in percent
timeFrame: 30±7 Days
measure: Rate of other Complications in percent
timeFrame: During the procedure
measure: Rate of Clinical Success in percent
timeFrame: During the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital affiliated to Capital University of Medical
state: Beijing
city: Xuzhou
country: China
facility: Xuzhou Third People Hospital
state: Jiangsu
city: Taiyuan
country: China
facility: Taiyuan Central Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Chest Hospita
state: Tianjin
Study officials:
affiliation: Beijing Anzhen Hospital affiliated to Capital University of Medical
name: Yujie Zhou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: