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This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin target-eluting Coronary Stent System | Device | Implantation of the rapamycin-eluting coronary stent system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With MACE (Major Acute Cardiovascular Events) | Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. | 1 month after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late Lumen Loss | In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter. | 4 months after stent implantation |
| Count of Participants With MACE (Major Acute Cardiovascular Events) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease. Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease. Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system |
| 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 | Count of Participants With MACE (Major Acute Cardiovascular Events) | Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. | Posted | Count of Participants | Participants | 1 month after stent implantation |
|
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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 | Treatment Group | Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease. Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TVR | Cardiac disorders | Target vessel revascularization, defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Zhang Haotian | Microport Medical, Shanghai, China | 8621-38954600 | 8552 | zhanght@microport.com |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. |
| 4 month after stent implantation |
| Percentage of In-stent Diameter Stenosis | Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest. | 4 months after stent implantation |
| In-stent Late Lumen Loss | In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter. | 13 month after stent implantation |
| Count of Participants With MACE (Major Acute Cardiovascular Events) | Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. | 13 month after stent implantation |
| Percentage of In-stent Diameter Stenosis | Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest. | 13 month after stent implantation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| Secondary | In-stent Late Lumen Loss | In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter. | Angiographic follow-up at 4 months was obtained in 19 patients. | Posted | Mean | Standard Deviation | mm | 4 months after stent implantation |
|
|
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| Secondary | Count of Participants With MACE (Major Acute Cardiovascular Events) | Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. | Posted | Count of Participants | Participants | 4 month after stent implantation |
|
|
|
| Secondary | Percentage of In-stent Diameter Stenosis | Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest. | Angiographic follow-up at 4 months was obtained in 19 patients. | Posted | Mean | Standard Deviation | percentage of lumen diameter | 4 months after stent implantation |
|
|
|
| Secondary | In-stent Late Lumen Loss | In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter. | Angiographic follow-up at 13months was obtained in 19 patients. | Posted | Mean | Standard Deviation | mm | 13 month after stent implantation |
|
|
|
| Secondary | Count of Participants With MACE (Major Acute Cardiovascular Events) | Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. | Posted | Count of Participants | Participants | 13 month after stent implantation |
|
|
|
| Secondary | Percentage of In-stent Diameter Stenosis | Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest. | Angiographic follow-up at 4 months was obtained in 19 patients. | Posted | Mean | Standard Deviation | percentage of lumen diameter | 13 month after stent implantation |
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| 1 |
| 21 |
| 2 |
| 21 |
| 0 |
| 21 |
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| Hemorrhagic stroke | Nervous system disorders | Hemorrhagic stroke is defined as a sudden onset of focal neurological deflicits due to cebral vascular bleeding that lasts more than 24 hours. |
|
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