Coronary StenosisNCT05509296
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
A study testing SINOMED CBC and NSE Coronary Dilatation Catheter in people with Coronary Stenosis and Coronary Artery Stenosis, run by Sino Medical Sciences Technology Inc. at 8 sites in China.
Trial summary
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- What is being tested?
- SINOMED CBC and NSE Coronary Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 8 sitesChina
- Study dates
- 20 Sep 2022to 23 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient is at least 18 to 75 years of age, male or not pregnant female.
- Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
- De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
- Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
- Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia.
- The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
- Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
- Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
Who cannot join
- Evidence of ongoing acute myocardial infarction within a week.
- Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
- Severe calcification and Target lesion in a severe angulation (> 45 degrees).
- Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%.
- Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl.
- Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation.
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- Patients with allergies to heparin and contrast media.
- Target lesion demonstrating severe dissection prior to planned deployment of the trial device.
- Visible thrombus at the target lesion.
- Patients received heart transplantation.
- Participation in another clinical trial (12 months after index procedure).
- Those who participated in another clinical trials, but did not reach the primary endpoint.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Peking University First Hospital
Beijing
Peking University Third Hospital
Beijing
Kaifeng Central Hospital
Kaifeng
The First People's Hospital of Lianyungang
Lianyungang
Tianjin Chest Hospital
Tianjin
Tianjin Forth Central Hospital
Tianjin
Wuxi People's Hospital
Wuxi
Xuzhou cancer hospital
Xuzhou
About this study
Official title: A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Read the detailed description
The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA.
After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention.
Subjects will be followed through hospital discharge.
- Being tested
- SINOMED CBC, NSE Coronary Dilatation Catheter
- Keywords
- Coronary dilation catheter, Percutaneous coronary artery dilatation, Restenosis, Cutting balloon catheter, scoring balloon catheter
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SINOMED CBCDevice
Also called cutting balloon catheter, scoring balloon catheter
The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
NSE Coronary Dilatation CatheterDevice
Also called Lacrosse NSE
The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
| Study group | Role | What they receive |
|---|---|---|
| SINOMED CBC | Experimental | Cutting balloon catheter (Sino Medical Sciences Technology Inc.) Receives: Device: SINOMED CBC |
| NSE Coronary Dilatation Catheter | Active comparator | NSE Coronary Dilatation Catheter (Goodman Co.,Ltd) Receives: Device: NSE Coronary Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device Procedural Success(Lesions Level)
Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%)
Measured: immediate post-intervention(approximately 1.4 hour)
Secondary outcomes (6)
Number of Participants With Procedural Success (Patient Level)
Defined as: ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%); and freedom from major adverse cardiac events (MACE) during hospitalization
Measured: During the hospital stay, up to 1 week
Number of Participants Who Experienced Target Lesion Failure (TLF)
A composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)
Measured: During the hospital stay, up to 1 week
Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE)
A composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization
Measured: During the hospital stay, up to 1 week
Number of Participants With Any Adverse Events (AE)
Report any AE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst、vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on.
Measured: During the hospital stay, up to 1 week
Number of Device Defects
Report any device defect during hospitalization
Measured: During the hospital stay, up to 1 week
Number of Participants With Serious Adverse Events (SAE)
Report any SAE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst、vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on.
Measured: During the hospital stay, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start20 Sep 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- A prospective, multicenter, randomized control,non-inferiority clinical study
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- jianping li, M.D/Ph.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509296
- Sponsor's protocol ID
- SN-CBC-202201
- Status last verified
- Mar 2026
- First submitted
- 16 Aug 2022
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05509296
- Acronym / sponsor ID
- SN-CBC-202201
- Keywords
- Coronary dilation catheter, Percutaneous coronary artery dilatation, Restenosis, Cutting balloon catheter, scoring balloon catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Sino Medical Sciences Technology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Detailed description
The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA.
After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention.
Subjects will be followed through hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized control,non-inferiority clinical study
| Arm | Type | Receives |
|---|---|---|
| SINOMED CBC | Experimental | Device: SINOMED CBCCutting balloon catheter (Sino Medical Sciences Technology Inc.) |
| NSE Coronary Dilatation Catheter | Active comparator | Device: NSE Coronary Dilatation CatheterNSE Coronary Dilatation Catheter (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 (8 listed)
- The patient is at least 18 to 75 years of age, male or not pregnant female.
- Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
- De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
- Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
- Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia.
Key exclusion criteria (12 listed)
- Evidence of ongoing acute myocardial infarction within a week.
- Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
- Severe calcification and Target lesion in a severe angulation (> 45 degrees).
- Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%.
- Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl.
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 |
|---|---|---|
| SINOMED CBCAlso: cutting balloon catheter, scoring balloon catheterThe Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion. | Device | SINOMED CBC |
| NSE Coronary Dilatation CatheterAlso: Lacrosse NSEThe Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion. | Device | NSE Coronary Dilatation Catheter |
Primary outcome
Number of Device Procedural Success(Lesions Level)
Time frame: immediate post-intervention(approximately 1.4 hour)
Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%)
6 secondary outcomes
Number of Participants With Procedural Success (Patient Level)
Time frame: During the hospital stay, up to 1 week
Number of Participants Who Experienced Target Lesion Failure (TLF)
Time frame: During the hospital stay, up to 1 week
Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE)
Time frame: During the hospital stay, up to 1 week
Number of Participants With Any Adverse Events (AE)
Time frame: During the hospital stay, up to 1 week
Number of Device Defects
Time frame: During the hospital stay, up to 1 week
Number of Participants With Serious Adverse Events (SAE)
Time frame: During the hospital stay, up to 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
jianping li, M.D/Ph.D principal investigator
Peking University First Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SINOMED CBC and NSE Coronary Dilatation Catheter in people with Coronary Stenosis and Coronary Artery Stenosis, run by Sino Medical Sciences Technology Inc. at 8 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 8 inclusion and 12 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Device Procedural Success(Lesions Level) (time frame: immediate post-intervention(approximately 1.4 hour)). 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 27 Mar 2026.