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

Coronary Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250193
• Other study ID #: VP-P-2019-006
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: DK Medical Technology (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Stenosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital affiliated to Capital University of Medical	Beijing	Beijing
China	Taiyuan Central Hospital	Taiyuan	Shanxi
China	Tianjin Chest Hospita	Tianjin	Tianjin
China	Xuzhou Third People Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
DK Medical Technology (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Acute Lumen Gain in mm (QCA)	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.	During the procedure
Secondary	Rate of Device success in percent	Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.	During the procedure
Secondary	Rate of Target Lesion Failure in percent	Defined as any Target Lesion Failure after procedure	30±7 Days
Secondary	Rate of Patient-oriented Composite Endpoint (POCE) in percent	Patient-oriented Composite Endpoint after procedure	30±7 Days
Secondary	Rate of other Complications in percent	Incidence of complications associated with the use of scoring balloon catheters	During the procedure
Secondary	Rate of Clinical Success in percent	Defined as <20% diameter stenosis after stenting for DCB, without in-hospital major adverse cardiac events/MI/TLR After PCI	During the procedure