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The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xience V | Active Comparator | Implantation of Xience V drug eluting stent |
|
| Firehawk | Experimental | Implantation of Firehawk drug eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firehawk | Device | Implantation of Firehawk drug eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 9 Months In-stent Late Lumen Loss | To observe in-stent late lumen loss after 9 months of stent implantation It means 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 months |
| Measure | Description | Time Frame |
|---|---|---|
| 9 Months In-stent Diameter Stenosis | the in-stent diameter stenosis 9 months post-procedure | 9 months |
| Target Lesion Failure(TLF) Rate | Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR). |
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Inclusion Criteria:
Exclusion Criteria:
Pre-specified OCT inclusion/exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, Pro & MD | Fuwai Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29166720 | Derived | Li CJ, Xu B, Guan CD, Gao RL; TARGETâ… Trial Investigators. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Nov 24;45(11):940-947. doi: 10.3760/cma.j.issn.0253-3758.2017.11.009. Chinese. | |
| 25678281 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xience V DES as Comparative Arm | Use Xience V DES as control group DES implantation: Implant DES for CAD cases |
| FG001 | MicroPort Firehawk DES | Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xience V DES as Comparative Arm | Use Xience V DES as control group DES implantation: Implant DES for CAD cases |
| BG001 | MicroPort Firehawk DES | Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 9 Months In-stent Late Lumen Loss | To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure | Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group. | Posted | Mean | Standard Deviation | mm | 9 months |
|
5 years
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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 | Xience V DES as Comparative Arm | Use Xience V DES as control group DES implantation: Implant DES for CAD cases |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Injury, poisoning and procedural complications | 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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| Xience V |
| Device |
Implantation of Xience V drug eluting stent |
|
| 1 years after index PCI |
| TLF(Target Lumen Failure) Rate | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. | 3 years after index PCI (Percutaneous Coronary Intervention) |
| TLF(Target Lumen Failure) | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. | 5 years after index PCI |
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 1 years after index PCI |
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 3 years after index PCI |
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 5 years after index PCI |
| 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. |
| 23685298 | Derived | Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB; TARGET I Investigators. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention. 2013 May 20;9(1):75-83. doi: 10.4244/EIJV9I1A12. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Use MicroPort's new generation of Firehawk drug eluting stent
DES implantation: Implant DES for CAD cases
|
|
|
| Secondary | 9 Months In-stent Diameter Stenosis | the in-stent diameter stenosis 9 months post-procedure | Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group. | Posted | Mean | Standard Deviation | percentage of diameter stenosis | 9 months |
|
|
|
|
| Secondary | Target Lesion Failure(TLF) Rate | Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR). | Posted | Number | percentage | 1 years after index PCI |
|
|
|
|
| Secondary | TLF(Target Lumen Failure) Rate | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. | 3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted. | Posted | Number | percentage | 3 years after index PCI (Percutaneous Coronary Intervention) |
|
|
|
|
| Secondary | TLF(Target Lumen Failure) | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. | 6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted. | Posted | Number | percentage | 5 years after index PCI |
|
|
|
|
| Secondary | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | Posted | Count of Participants | Participants | 1 years after index PCI |
|
|
|
|
| Secondary | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted. | Posted | Count of Participants | Participants | 3 years after index PCI |
|
|
|
| Secondary | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted. | Posted | Count of Participants | Participants | 5 years after index PCI |
|
|
|
| 8 |
| 225 |
| 46 |
| 225 |
| 0 |
| 225 |
| EG001 | MicroPort Firehawk DES | Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases | 7 | 227 | 28 | 227 | 0 | 227 |
| myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| coronary revascularization | Surgical and medical procedures | 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 |