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Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.
The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNERGYTM Coronary Stent System | Experimental | Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNERGYTM Coronary Stent System | Device | SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Revascularization (TLR) Rate | 30 days | |
| Target Lesion Failure (TLF) Rate | 30 days | |
| Target Vessel Revascularization (TVR) Rate |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yalin Han | Shenyang Northern Hospital (The General Hospital of Shenyang Military Region) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AeroSpace center hospital | Beijing | China | ||||
| the second hospital of Jilin Unversity |
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| ID | Title | Description |
|---|---|---|
| FG000 | SYNERGYTM Coronary Stent System | Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SYNERGYTM Coronary Stent System | Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium 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 | Technical Success Rate | Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician | Posted | Number | percentage of participants | 1 day |
|
|
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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 | SYNERGYTM Coronary Stent System | Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Hanyaling | The General Hospital of ShenYang Military | 02428851876 | hanyl@medmail.com.cn |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 30 days |
| Target Vessel Failure (TVF) Rate | 30 days |
| Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate | 30 days |
| Changcun |
| China |
| Daqing General Oil Field Hospital | Daqing | China |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| The First Hospital of Lanzhou University | Lanzhou | China |
| General Hospital of SY Military Institute | Shenyang | China |
| TEDA International Cardiovascular Hospital | Tianjin | China |
| Wuhan Asia Heart Hospital | Wuhan | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Target Lesion Revascularization (TLR) Rate | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Target Lesion Failure (TLF) Rate | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Target Vessel Revascularization (TVR) Rate | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Target Vessel Failure (TVF) Rate | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate | Posted | Number | percentage of participants | 30 days |
|
|
|
| 1 |
| 103 |
| 7 |
| 103 |
| General disorders and administration site conditions | General disorders |
|
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