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The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.
This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firehawk | Experimental | Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIREHAWK biodegradable polymer rapamycin-eluting stent | Device | DES PCI for CAD |
|
| Measure | Description | Time Frame |
|---|---|---|
| TLF (Target Lesion Failure) Rate | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | 12 months after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Implantation Success Rate (SIS Rate) | Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III | immediately after the procedure |
| Patient-related Cardiovascular Clinical Composite Endpoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, M.D., Prof. | Fu Wai Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25678281 | Derived | Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Firehawk | Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Firehawk | Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD |
| 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 | TLF (Target Lesion Failure) Rate | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | Posted | Number | percentage of participants with TLF | 12 months after index procedure |
|
|
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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 | Firehawk | Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perioperative myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kefei Li | Shanghai Microport Medical (Group) Co.,Ltd. | +86-21-38954600×6700 | kfli@microport.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. |
| 1 years after index PCI |
| Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | 3 years after index PCI |
| Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | 5 years after index PCI |
| TLF (Target Lesion Failure) | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | 1 years after index PCI |
| TLF (Target Lesion Failure) | Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | 3 years after index PCI |
| TLF (Target Lesion Failure) | Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure | 5 years after index PCI |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Stent Implantation Success Rate (SIS Rate) | Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III | Posted | Number | percentage of participants with SIS | immediately after the procedure |
|
|
|
| Secondary | Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | Posted | Count of Participants | Participants | 1 years after index PCI |
|
|
|
| Secondary | Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | Posted | Count of Participants | Participants | 3 years after index PCI |
|
|
|
| Secondary | Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | Posted | Count of Participants | Participants | 5 years after index PCI |
|
|
|
| Secondary | TLF (Target Lesion Failure) | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | Posted | Number | percentage of participants with TLF | 1 years after index PCI |
|
|
|
| Secondary | TLF (Target Lesion Failure) | Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | Posted | Count of Participants | Participants | 3 years after index PCI |
|
|
|
| Secondary | TLF (Target Lesion Failure) | Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure | Posted | Count of Participants | Participants | 5 years after index PCI |
|
|
|
| 30 |
| 683 |
| 112 |
| 683 |
| 0 |
| 730 |
| Target lesion revascularization | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Death | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Definite/probable in-stent thrombosis | Cardiac disorders | MedDRA | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |