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 (38mm) 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 |
|---|---|---|---|
| treatment group | Experimental | Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin target-eluting coronary stent systems (38mm) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late Lumen Loss | 9 month after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 30 days after stent implantation |
| 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 | Treatment Group | Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm) |
| 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 Lumen Loss | A sum of 31 patients with 33 target lesions were analyzed by Quantitative Coronary Angiography (QCA). 7 participants did not participate in 9 month angiographic follow up. | Posted | Mean | Standard Deviation | mm | 9 month after stent implantation | target stent | target stent |
|
|
4 year follow up
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 | Treatment Group | Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Target Lesion Revascularization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated myocardial enzyme | Cardiac disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haotian Zhang | Shanghai Microport Medical (Company) Co.,Ltd. | +86-21-38954600 | 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
all patients implanted Firehawk stent of new specification (38mm long)
Not provided
Not provided
Not provided
Not provided
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) |
| 6months after stent implantation |
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 12 months after stent implantation |
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 2 years after stent implantation |
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 3 years after stent implantation |
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 4 years after stent implantation |
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 30 days after stent implantation |
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 6 months after stent implantation |
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 12 months after stent implantation |
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 2 years after stent implantation |
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 3 years after stent implantation |
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 4 years after stent implantation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes Mellitus (DM) history | Count of Participants | Participants |
|
| Coronary Artery Disease (CAD) history | Count of Participants | Participants |
|
| hypertension (HTN) history | Count of Participants | Participants |
|
| Cigarette usage | Count of Participants | Participants |
|
| Myocardial Infarction (MI) history | Count of Participants | Participants |
|
| target stent |
|
|
| Secondary | Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | Posted | Count of Participants | Participants | 30 days after stent implantation |
|
|
|
| Secondary | Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | Posted | Count of Participants | Participants | 6months after stent implantation |
|
|
|
| Secondary | Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | Posted | Count of Participants | Participants | 12 months after stent implantation |
|
|
|
| Secondary | Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | Posted | Count of Participants | Participants | 2 years after stent implantation |
|
|
|
| Secondary | Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | One participant was lost during 3 years follow up. | Posted | Count of Participants | Participants | 3 years after stent implantation |
|
|
|
| Secondary | Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | One participant was lost during 4 years follow up. | Posted | Count of Participants | Participants | 4 years after stent implantation |
|
|
|
| Secondary | Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | Posted | Count of Participants | Participants | 30 days after stent implantation |
|
|
|
| Secondary | Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | Posted | Count of Participants | Participants | 6 months after stent implantation |
|
|
|
| Secondary | Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | Posted | Count of Participants | Participants | 12 months after stent implantation |
|
|
|
| Secondary | Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | Posted | Count of Participants | Participants | 2 years after stent implantation |
|
|
|
| Secondary | Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | One participant was lost during 3 years follow up. | Posted | Count of Participants | Participants | 3 years after stent implantation |
|
|
|
| Secondary | Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | One participant was lost during 4 years follow up. | Posted | Count of Participants | Participants | 4 years after stent implantation |
|
|
|
| 0 |
| 38 |
| 15 |
| 38 |
| 25 |
| 38 |
| Angina | Cardiac disorders | Systematic Assessment |
|
| Rehospitalization | General disorders | Systematic Assessment |
|
| lymphoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| non-Target Vessel Revascularization | Cardiac disorders | Systematic Assessment |
|
| acute cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Diastolic dysfunction | Cardiac disorders | Systematic Assessment |
|
| gastric antrum erosion | Gastrointestinal disorders | Systematic Assessment |
|
| senile cataract | Eye disorders | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| corneal ulcer | Eye disorders | Systematic Assessment |
|
| hypokalemia | General disorders | Systematic Assessment |
|
| aneurysm | Vascular disorders | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| heart discomfort after movation | Cardiac disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Short breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| renal cyst | Renal and urinary disorders | Systematic Assessment |
|
| premature ventricular contraction | Cardiac disorders | Systematic Assessment |
|
| myocardial injury | Cardiac disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| vertigo | Nervous system disorders | Systematic Assessment |
|
| palpitation | Cardiac disorders | Systematic Assessment |
|
| angina | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided