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| ID | Type | Description | Link |
|---|---|---|---|
| XV02RS |
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The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex PCI strategy for bifurcation coronary lesions | Active Comparator | Stenting main vessel and T-stenting for the side branch |
|
| Simple PCI strategies for bifurcation coronary lesions | Active Comparator | Stenting main vessel, with provisional stenting for the side branch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A. | Device | Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique. Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Combined rate of events (cardiac death, myocardial infarction and TLR) | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael J Ruiz-Salmeron, PhD | Contact | 0034955693440 | rjruizsalmeron@yahoo.es |
| Name | Affiliation | Role |
|---|---|---|
| Federico Gimeno, MD | Hospital Clinico Universitario Valladolid | Principal Investigator |
| Bruno Garcia, MD | Hospital Valle de Hebron. Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | Sevilla | 41007 | Spain |
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|
| Ramiro Trillo, MD |
| Hospital Clínico Santiago |
| Principal Investigator |
| Jose Moreu, MD | Hospital Virgen de la Salud | Principal Investigator |
| Javier Goicolea, MD | Hospital Puerta de Hierro, Madrid | Principal Investigator |
| Raul Moreno, MD | Hospital Universitario La Paz | Principal Investigator |
| Jose F Diaz, MD | Hospital Juan Ramon Jimenez. Huelva | Principal Investigator |
| Jose M Hernandez, MD | Hospital Clinico de Malaga | Principal Investigator |
| Ramon Lopez-Palop, MD | Hospital San Juan. Alicante | Principal Investigator |
| Mariano Valdes, MD | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| Pascual Bordes, MD | Hospital Universitario. Alicante | Principal Investigator |
| Jose R Rumoroso, MD | Hospital Galdakao. Vizcaya | Principal Investigator |
| University Hospital Virgen Macarena | Not yet recruiting | Seville | Seville | 41007 | Spain |
|
| 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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