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

Primary Purpose

Coronary Stenosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DK ScoreTM Coronary Scoring Balloon
Non-Slip Element Coronary Dilatation Catheter
Sponsored by
DK Medical Technology (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Stenosis focused on measuring Scoring balloon; DK Score; NSE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital affiliated to Capital University of Medical
  • Xuzhou Third People Hospital
  • Taiyuan Central Hospital
  • Tianjin Chest Hospita

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DK ScoreTM Coronary Scoring Balloon (DK Score)

Non-Slip Element Coronary Dilatation Catheter (NSE)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Device success in percent
Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.
Rate of Target Lesion Failure in percent
Defined as any Target Lesion Failure after procedure
Rate of Patient-oriented Composite Endpoint (POCE) in percent
Patient-oriented Composite Endpoint after procedure
Rate of other Complications in percent
Incidence of complications associated with the use of scoring balloon catheters
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

Full Information

First Posted
February 5, 2022
Last Updated
February 23, 2022
Sponsor
DK Medical Technology (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05250193
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DK Medical Technology (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
Scoring balloon; DK Score; NSE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DK ScoreTM Coronary Scoring Balloon (DK Score)
Arm Type
Experimental
Arm Description
DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD
Arm Title
Non-Slip Element Coronary Dilatation Catheter (NSE)
Arm Type
Active Comparator
Arm Description
Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD
Intervention Type
Device
Intervention Name(s)
DK ScoreTM Coronary Scoring Balloon
Other Intervention Name(s)
DK Score
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non-Slip Element Coronary Dilatation Catheter
Other Intervention Name(s)
NSE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Acute Lumen Gain in mm (QCA)
Description
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.
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Rate of Device success in percent
Description
Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.
Time Frame
During the procedure
Title
Rate of Target Lesion Failure in percent
Description
Defined as any Target Lesion Failure after procedure
Time Frame
30±7 Days
Title
Rate of Patient-oriented Composite Endpoint (POCE) in percent
Description
Patient-oriented Composite Endpoint after procedure
Time Frame
30±7 Days
Title
Rate of other Complications in percent
Description
Incidence of complications associated with the use of scoring balloon catheters
Time Frame
During the procedure
Title
Rate of Clinical Success in percent
Description
Defined as <20% diameter stenosis after stenting for DCB, without in-hospital major adverse cardiac events/MI/TLR After PCI
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou, Dr.
Organizational Affiliation
Beijing Anzhen Hospital affiliated to Capital University of Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital affiliated to Capital University of Medical
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Xuzhou Third People Hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Taiyuan Central Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Tianjin Chest Hospita
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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