Coronary StenosisNCT05250193
DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)
A study testing DK ScoreTM Coronary Scoring Balloon and Non-Slip Element Coronary Dilatation Catheter in people with Coronary Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- DK ScoreTM Coronary Scoring Balloon and Non-Slip Element Coronary Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 24 Mar 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital affiliated to Capital University of Medical
Beijing, Beijing Municipality
Taiyuan Central Hospital
Taiyuan, Shanxi
Tianjin Chest Hospita
Tianjin, Tianjin Municipality
Xuzhou Third People Hospital
Xuzhou, Jiangsu
About this study
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
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.
Read the 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.
- Conditions
- Coronary Stenosis
- Being tested
- DK ScoreTM Coronary Scoring Balloon, Non-Slip Element Coronary Dilatation Catheter
- Keywords
- Scoring balloon; DK Score; NSE
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DK ScoreTM Coronary Scoring BalloonDevice
Also called DK Score
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 CatheterDevice
Also called NSE
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.
| Study group | Role | What they receive |
|---|---|---|
| DK ScoreTM Coronary Scoring Balloon (DK Score) | Experimental | DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD Receives: 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 Receives: Device: Non-Slip Element Coronary Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
Secondary outcomes (5)
Rate of Device success in percent
Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.
Measured: During the procedure
Rate of Target Lesion Failure in percent
Defined as any Target Lesion Failure after procedure
Measured: 30±7 Days
Rate of Patient-oriented Composite Endpoint (POCE) in percent
Patient-oriented Composite Endpoint after procedure
Measured: 30±7 Days
Rate of other Complications in percent
Incidence of complications associated with the use of scoring balloon catheters
Measured: During the procedure
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
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start24 Mar 2021
- Primary completion2 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yujie Zhou, Dr., Principal investigator, Beijing Anzhen Hospital affiliated to Capital University of Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250193
- Sponsor's protocol ID
- VP-P-2019-006
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05250193
- Acronym / sponsor ID
- VP-P-2019-006
- Conditions
- Coronary Stenosis
- Keywords
- Scoring balloon; DK Score; NSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DK ScoreTM Coronary Scoring Balloon (DK Score) | Experimental | Device: DK ScoreTM Coronary Scoring BalloonDK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD |
| Non-Slip Element Coronary Dilatation Catheter (NSE) | Active comparator | Device: Non-Slip Element Coronary Dilatation CatheterNon-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- AMI within 1 week.
- Patients has congestive heart failure or NYHA IV.
- Renal dysfunctional (CRE>443umol/L).
- Patient underwent heat transplant.
- Pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DK ScoreTM Coronary Scoring BalloonAlso: DK ScoreAfter 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. | Device | DK ScoreTM Coronary Scoring Balloon (DK Score) |
| Non-Slip Element Coronary Dilatation CatheterAlso: NSEAfter pre-dilation balloon is used (if any), NSE is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment. | Device | Non-Slip Element Coronary Dilatation Catheter (NSE) |
Primary outcome
Numerical Acute Lumen Gain in mm (QCA)
Time frame: 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.
5 secondary outcomes
Rate of Device success in percent
Time frame: During the procedure
Rate of Target Lesion Failure in percent
Time frame: 30±7 Days
Rate of Patient-oriented Composite Endpoint (POCE) in percent
Time frame: 30±7 Days
Rate of other Complications in percent
Time frame: During the procedure
Rate of Clinical Success in percent
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yujie Zhou, Dr. principal investigator
Beijing Anzhen Hospital affiliated to Capital University of Medical
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DK ScoreTM Coronary Scoring Balloon and Non-Slip Element Coronary Dilatation Catheter in people with Coronary Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Acute Lumen Gain in mm (QCA) (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.