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The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss.
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects, randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be randomized using an interactive voice response system (IVRS).
Due to the design characteristics of the devices, the study investigators and operators can not be blinded. However, the clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the subjects to avoid a potential bias in the adjudication process of events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taxus Liberte Paclitaxel-Eluting Coronary Stent System | Active Comparator | Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS). |
|
| Medtronic Resolute (Zotarolimus-eluting stent) | Experimental | Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxus Liberte Paclitaxel-Eluting Coronary Stent System | Device | Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| in-stent late lumen loss (LLL) | in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Definition 1: The attainment of <50% residual stenosis of the target lesion using only the assigned device. Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
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Inclusion Criteria:
Patient must meet all of the following criteria to be eligible for treatment in the trial:
Exclusion Criteria:
Patients will be excluded from the trial if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Shuzheng Lv | An Zhen Hospital | Principal Investigator |
| Yundai Chen | Chinese PLA General Hospital | Principal Investigator |
| Zhimin Du | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Bo Xu | Beijing Fu Wai Hospital | Principal Investigator |
| Yuejin Yang, MD | Fu Wai Hospital, Beijing, China | Principal Investigator |
| Zuyi Yuan | First Affiliated Hospital of Medical College of ZI'AN Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An Zhen Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| Beijing Fu Wai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23523240 | Result | Xu B, Yang Y, Yuan Z, Du Z, Wong SC, Genereux P, Lu S; RESOLUTE China RCT Investigators. Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial. JACC Cardiovasc Interv. 2013 Jul;6(7):664-70. doi: 10.1016/j.jcin.2013.03.001. Epub 2013 Mar 21. |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D003327 | Coronary Disease |
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|
| Resolute Zotarolimus-Eluting Coronary Stent System | Device | Resolute Zotarolimus-Eluting Coronary Stent System Implantation |
|
|
| at the end of the index procedure or during hospital stay |
| Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| Myocardial infarction | All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| MACE composite endpoint | Death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization | Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| All revascularizations | Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| Target lesion failure (TLF) | A composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| Target vessel failure (TVF) | A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| Stent thrombosis | As determined by Medtronic historic and ARC definitions. | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr |
| Lesion success | Definition 1: The attainment of <50% residual stenosis of the target lesion using any percutaneous method. Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. | At the end of the index procedure or during hospital stay |
| Procedure success | Definition 1: The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE. Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. | At the end of the index procedure or during hospital stay |
| Beijing |
| Beijing Municipality |
| 100037 |
| China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| First Affiliated Hospital of Medical College of XI'AN Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |