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The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DES Limus Carbostent Coronary Stent | Experimental |
| |
| Taxus Liberté Coronary Stent | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DES Limus Carbostent | Device | DES Limus Carbostent Carbofilm Coated Coronary Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| angiographic efficacy measurement (mm) | in-stent Late Lumen Loss (LLL) measurement by angiography | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| QCA measurements in-stent and in-segment | 180 days | |
| IVUS measurements | 180 days | |
| Incidence of cardiac death (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Carrié, Prof | Hôpital de Rangueil, Toulouse Cedex 4 - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Ziekenhuis Middelheim | Antwerp | Belgium | ||||
| Ziekenhuis Oost Limburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22284328 | Derived | Carrie D, Berland J, Verheye S, Hauptmann KE, Vrolix M, Violini R, Dibie A, Berti S, Maupas E, Antoniucci D, Schofer J. A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions. J Am Coll Cardiol. 2012 Apr 10;59(15):1371-6. doi: 10.1016/j.jacc.2011.12.009. Epub 2012 Jan 25. |
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| Taxus Liberté Stent | Device | Taxus Liberté Coronary Stent |
|
| 30 days, 180 days, 1, 2 , 3, 4 and 5 years |
| Stent Thrombosis | acute, 30 days, 180 days, 1 year, > 1 year |
| Acute success (Device and Procedural success) | acute |
| Incidence of Myocardial Infarction (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Incidence of clinically indicated TLR (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Incidence of all deaths (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Incidence of all repeat revascularization (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Genk |
| Belgium |
| Clinique les Franciscaines | Nîmes | France |
| Institut Mutualiste Montsouris | Paris | France |
| Clinique Saint-Hilaire | Rouen | France |
| Hôpital de Rangueil | Toulouse | France |
| Medizinisches Versorgungszentrum | Hamburg | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | Germany |
| Azienda Ospedaliera Careggi | Florence | Italy |
| Istituto di Fisiologia Clinica del CNR | Massa | Italy |
| Ospedale S. Camillo | Roma | Italy |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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