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

NCT05250193 | Completed

• 1 other identifier: VP-P-2019-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Stenosis

Keywords

Scoring balloon; DK Score; NSE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of Device success in percent

  During the procedure

• Rate of Target Lesion Failure in percent

  30±7 Days

• Rate of Patient-oriented Composite Endpoint (POCE) in percent

  30±7 Days

• Rate of other Complications in percent

  During the procedure

• Rate of Clinical Success in percent

  During the procedure

Study Arms (2)

DK ScoreTM Coronary Scoring Balloon (DK Score)

EXPERIMENTAL

DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD

Device: DK ScoreTM Coronary Scoring Balloon

Non-Slip Element Coronary Dilatation Catheter (NSE)

ACTIVE COMPARATOR

Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD

Device: Non-Slip Element Coronary Dilatation Catheter

Interventions

DK ScoreTM Coronary Scoring Balloon DEVICE

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.

Also known as: DK Score

DK ScoreTM Coronary Scoring Balloon (DK Score)

Non-Slip Element Coronary Dilatation Catheter DEVICE

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.

Also known as: NSE

Non-Slip Element Coronary Dilatation Catheter (NSE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• DK Medical Technology (Suzhou) Co., Ltd.: lead

Study Sites (4)

Beijing Anzhen Hospital affiliated to Capital University of Medical

Beijing, Beijing Municipality, China

Location

Xuzhou Third People Hospital

Xuzhou, Jiangsu, China

Location

Taiyuan Central Hospital

Taiyuan, Shanxi, China

Location

Tianjin Chest Hospita

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yujie Zhou, Dr.

  Beijing Anzhen Hospital affiliated to Capital University of Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 22, 2022
• Study Start: March 24, 2021
• Primary Completion: September 2, 2021
• Study Completion: December 30, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)