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| Name | Class |
|---|---|
| Azienda Ospedaliero-Universitaria di Modena | OTHER |
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Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.
Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months.
Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12 months) of dual antiplatelet therapy
Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taxus Element | Active Comparator | Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN) |
|
| Xience Prime | Active Comparator | Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL) |
|
| Integrity Resolute | Active Comparator | Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxus Element stent | Device | paclitaxel-eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of glucose levels on repeat revascularization | Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate | 1 year |
| Target Lesion Revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrico Romagnoli, MD, PhD | Policlinico Casilino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Policlinico-Universitaria di Modena | Modena | Modena | 41100 | Italy | ||
| Policlinico Casilino |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Integrity Resolute stent | Device | ABT 578-eluting stent |
|
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| Xience Prime stent | Device | Everolimus-eluting stent |
|
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Target lesion revascularization at 12, 24 and 36 months |
| 1, 2 and 3 year |
| Effect of dual antiplatelet therapy on outcome | Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome | 3 year |
| Rome |
| Rome |
| 00100 |
| Italy |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |