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| Name | Class |
|---|---|
| ClinLogix. LLC | INDUSTRY |
This is a six (6) month, randomized, un-blinded, study to assess the safety and performance of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mach-5 Grooved | Experimental | grooved |
|
| Mach 5 Bare Metal | Experimental | bare metal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary stent | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| late lumen loss rate by Quantative/ Qualtative Cornary Angiographia | 6 month | |
| total percentage of strut coverage by Optical Coherence Tomography analysis | 6 month | |
| Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices. | 6 month | |
| binary restenosis rate by Quantative/ Qualtative Cornary Angiographia | 6 month |
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Inclusion Criteria:
Intra-Procedure Angiographic Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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