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| Name | Class |
|---|---|
| Labcoat, Ltd. | INDUSTRY |
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Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the efficacy of the product.
The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | JACTAX LD DES |
|
| II | Active Comparator | TAXUS™ Libertè™ DES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JACTAX LD DES | Device | Drug Eluting Stent |
| |
| TAXUS™ Libertè™ DES |
| Measure | Description | Time Frame |
|---|---|---|
| MACE rate at 9 months | 9 months |
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General Inclusion Criteria:
Angiographic Inclusion Criteria
General Exclusion Criteria:
Angiographic Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Eberhard Grube | Elizabeth Hospital, Essen Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Bonn | Bonn | Germany | ||||
| Cardiovascular Center Sankt Katharinen |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
Drug Eluting Stent |
|
| Frankfurt |
| Germany |
| Hamburg University CardioVascular Center | Hamburg | Germany |
| HELIOS Klinikum | Siegburg | Germany |
| Krankenhaus der Barmherzigen Bruder | Trier | Germany |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |