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| Name | Class |
|---|---|
| CCRF Inc., Beijing, China | INDUSTRY |
| OrbusNeich Medical (Shenzhen), Co. Ltd. | INDUSTRY |
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To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.
This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 436 subjects. All subjects enrolled will be randomly assigned to the test group (n=218) and the control group (n=218). Subjects in the test group and the control group will receive Combo stents and Nano stents respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OrbusNeich Combo stentâ„¢ | Experimental | The Combo Stent is composed of the OrbusNeich R stentâ„¢, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. |
|
| Nano Polymer-free sirolimus-eluting stent system | Active Comparator | The Nano polymer-free sirolimus-eluting stent produced by LePu medical. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OrbusNeich Combo stentâ„¢ | Device | The Combo Stent is composed of the OrbusNeich R stentâ„¢, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. |
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late lumen loss (LLL) | In-segment late lumen loss (LLL) refers to within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. | 9 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented target lesion failure (TLF) | The device-oriented target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (i-TLR) | 30 days, 6 months, 12 months and annually up to 5 years |
| Patient-oriented composite endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tao Ling, M.D. | The First Affiliated Hospital of the Fourth Medical University | Principal Investigator |
| Xu Bo, M.D | The Secondary Affiliated Hospital of Harbin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daqing General Oilfield Hospital | Daqing | Heilongjiang | China | |||
| Jiangsu Province Hospital |
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| sirolimus-eluting stent system | Device |
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The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization |
| 30 days, 6 months, 12 months and annually up to 5 years |
| In-stent late lumen loss (LLL) | 9 months post-procedure |
| In-stent and In-segment binary restenosis (BR) | 9 months post-procedure |
| In-stent and In-segment minimal lumen diameter (MLD) | 9 months post-procedure |
| Definite and probable stent thrombosis (ST) | Definite and probable stent thrombosis (ST) in acute, sub-acute, late and very late period per Academic Research Consortium (ARC) definition criteria | acute (0-24 hours), sub-acute (24 Hours to 30 Days), late (30 Days to 1 year) and very late (1 year to 5 years) period per Academic Research Consortium (ARC) definition criteria |
| Nanjing |
| Jiangsu |
| China |
| Nanjing First Hospital | Nanjing | Jiangsu | China |
| China Japan Union Hospital of Jilin University | Changchun | Jilin | China |
| The people Hospital of Liaoning Province | Shenyang | Liaoning | China |
| The Secondary Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Kunming General Hospital of Chengdu Military region | Kunming | Yunnan | China |
| Beijing Chao Yang Hospital | Beijing | China |
| The Military General Hospital of Beijing PLA | Beijing | China |
| Bethune International Peace Hospital | Shijiazhuang | China |
| TEDA International Cardiovascular Hospital | Tianjin | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| Tianjing Chest Hospital | Tianjing | China |
| The First Affiliated Hospital of the Fourth Military Medical University | Xi'an, Shanxi | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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