Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new specifications (Diameter 2.25mm)of Firehawk stent | Experimental | Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FirehawkTM 2.25mm | Device | Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late Loss | the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure. | 9 month after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | 12 months |
| Number of Participants With Target Lesion Failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, MD | Fu Wai Hospital & National Center for Cardiovascular Diseases in China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Wai Hospital | Beijing | Beijing Municipality | 100037 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | New Specifications (Diameter 2.25mm)of Firehawk Stent | Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | New Specifications (Diameter 2.25mm)of Firehawk Stent | Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | In-stent Late Loss | the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure. | Posted | Mean | Standard Deviation | mm | 9 month after stent implantation |
|
|
4 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Specifications (Diameter 2.25mm)of Firehawk Stent | Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| target lesion revascularization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated myocardial enzyme | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| HT Zhang | Shanghai Microport Medicine | +862138954600 | 8552 | zhanght@microport.com |
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
| 2 years |
| Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | 3 years |
| Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | 4 years |
| Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | 12 months |
| Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | 2 years |
| Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | 3 years |
| Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | 4 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | One missed participant in 3 years follow up | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Target Lesion Failure | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization | Two missed participant in 4 years follow up | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | One missed participant in 3 years follow up | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With MACE | a composite endpoint of all cause death, any myocardial infarction and any revascularization | One missed participant in 3 years follow up | Posted | Count of Participants | Participants | 4 years |
|
|
|
| 1 |
| 38 |
| 28 |
| 38 |
| 32 |
| 38 |
| in-stent restenosis | Cardiac disorders | Systematic Assessment |
|
| angina | Cardiac disorders | Systematic Assessment |
|
| hypotension | Vascular disorders | Systematic Assessment |
|
| rehospitalization | General disorders | Systematic Assessment |
|
| non target lesion revascularization | Cardiac disorders | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
|
| renal artery implantation | Vascular disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Death of cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| No-reflow phenomenon | Cardiac disorders | Systematic Assessment |
|
| intermediate lesion | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Repeat chest & back pain | General disorders | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| abnormal liver function | General disorders | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cervical spondylopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| soft tissue disease | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| perioperation hypotension | Vascular disorders | Systematic Assessment |
|
| perioperation slow heart beat | Cardiac disorders | Systematic Assessment |
|
| Sleeping disorder | Psychiatric disorders | Systematic Assessment |
|
| Weight loss | General disorders | Systematic Assessment |
|
| Gastroesophageal disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Varicosity | Vascular disorders | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Heart dysfunction | Cardiac disorders | Systematic Assessment |
|
| Myocardial injury | Cardiac disorders | Systematic Assessment |
|
| rapid heart beat | Cardiac disorders | Systematic Assessment |
|
| Chest distress | Cardiac disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| unsatifactory blood glucose control | Metabolism and nutrition disorders | Systematic Assessment |
|
| lumbago | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Deaf | Ear and labyrinth disorders | Systematic Assessment |
|
| syncope | Nervous system disorders | Systematic Assessment |
|
| Numbness | Nervous system disorders | Systematic Assessment |
|
| peripheral neuropathy | Nervous system disorders | Systematic Assessment |
|
| disc herniation | Nervous system disorders | Systematic Assessment |
|
| Fasciitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided