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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SINOMED CBC | Experimental | Cutting balloon catheter (Sino Medical Sciences Technology Inc.) |
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| NSE Coronary Dilatation Catheter | Active Comparator | NSE Coronary Dilatation Catheter (Goodman Co.,Ltd) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SINOMED CBC | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%) | immediate post-intervention(approximately 1.4 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the hospital stay, up to 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianping li, M.D/Ph.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China | ||||
| Peking University Third Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | SINOMED CBC | Cutting balloon catheter (Sino Medical Sciences Technology Inc.) SINOMED CBC: 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2022 | Jan 22, 2026 |
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A prospective, multicenter, randomized control,non-inferiority clinical study
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| NSE Coronary Dilatation Catheter | Device | 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. |
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| 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) | 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 | 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. | During the hospital stay, up to 1 week |
| Number of Device Defects | Report any device defect during hospitalization | 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. | During the hospital stay, up to 1 week |
| Beijing |
| China |
| Kaifeng Central Hospital | Kaifeng | China |
| The First People's Hospital of Lianyungang | Lianyungang | China |
| Tianjin Chest Hospital | Tianjin | China |
| Tianjin Forth Central Hospital | Tianjin | China |
| Wuxi People's Hospital | Wuxi | China |
| Xuzhou cancer hospital | Xuzhou | China |
| NSE Coronary Dilatation Catheter |
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd) NSE Coronary Dilatation 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. |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) comprised 66 subjects in the experimental group and 68 subjects in the control group. One subject randomized to the experimental group was excluded from the analysis due to withdrawal of consent prior to receiving the experimental balloon. One subject randomized to the control group was excluded for meeting exclusion criterion 1 and did not receive the control balloon.
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| ID | Title | Description |
|---|---|---|
| BG000 | SINOMED CBC | Cutting balloon catheter (Sino Medical Sciences Technology Inc.) SINOMED CBC: 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. |
| BG001 | NSE Coronary Dilatation Catheter | NSE Coronary Dilatation Catheter (Goodman Co.,Ltd) NSE Coronary Dilatation 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Number of target lesions | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%) | lesions | Posted | Number | lesions | immediate post-intervention(approximately 1.4 hour) | Lesions | Lesions |
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| Secondary | 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 | Posted | Count of Participants | Participants | During the hospital stay, up to 1 week |
|
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| Secondary | 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) | Posted | Count of Participants | Participants | During the hospital stay, up to 1 week |
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| Secondary | 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 | Posted | Count of Participants | Participants | During the hospital stay, up to 1 week |
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| Secondary | 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. | Posted | Count of Participants | Participants | During the hospital stay, up to 1 week |
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| Secondary | Number of Device Defects | Report any device defect during hospitalization | Posted | Count of Participants | Participants | During the hospital stay, up to 1 week |
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| Secondary | 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. | Posted | Count of Participants | Participants | During the hospital stay, up to 1 week |
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During the hospital, up to 1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SINOMED CBC | Cutting balloon catheter (Sino Medical Sciences Technology Inc.) SINOMED CBC: 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. | 0 | 66 | 1 | 66 | 21 | 66 |
| EG001 | NSE Coronary Dilatation Catheter | NSE Coronary Dilatation Catheter (Goodman Co.,Ltd) NSE Coronary Dilatation 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. | 0 | 68 | 1 | 68 | 18 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
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| Mesenteric arteriosclerosis | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperlipemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Myocardial injury | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Gingival hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Peripheral edema | Injury, poisoning and procedural complications | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
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| Visual field loss | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Piper | Sino Medical Sciences Technology Inc. | 010 8048 2242 | pichaoqiong@sinomed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2023 | Jan 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Male |
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| 2 Leisons |
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