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Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent.
The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients undergoing percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titanium bare metal stent | Experimental | Titanium bare metal stent (Titan2®, Hexacath, Paris, France) |
|
| Everolimus Drug Eluting Stent | Experimental | Xience-V®, Abbott Vascular, Santa Clara, California, USA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium bare metal stent (Titan2®) | Device | Titan2®, Hexacath, Paris, France |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| Late luminal loss | Comparison of late luminal loss within the in-segment zone at 9 months between the two treatment strategies in the subgroup of patients with angiographic follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Ramon Lopez-Minguez, MD | Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center, Satakunta Hospital, Pori, Finland | Satakunta | Pori | 28500 | Finland | ||
| Hospital de Torrevieja |
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| Everolimus Drug Eluting Stent (Xience-V®) |
| Device |
Xience-V®, Abbott Vascular, Santa Clara, California, USA |
|
| Torrevieja |
| Alicante |
| 03180 |
| Spain |
| Hospital Universitario Infanta Cristina | Badajoz | Badajoz | 06006 | Spain |
| Hospital Puerto Real de Cádiz | Puerto Real | Cadiz | 11510 | Spain |
| Hospital Juan Ramón Jiménez de Huelva | Huelva | Huelva | 21005 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Virgen de la Salud de Toledo | Toledo | Toledo | 45004 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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