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The primary objective is to evaluate the use of the AngioGuardâ„¢ device combined with the Bx Velocityâ„¢ on patient outcome at one month.
This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuardâ„¢ device and Bx Velocityâ„¢ stent and will be followed for six-months post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AngioGuardâ„¢ device and Bx Velocityâ„¢ stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emboli capturing guidewire device combined with stent | Device | AngioGuardâ„¢ device and Bx Velocityâ„¢ stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical success of the AngioGuardâ„¢ device combined with the Bx Velocityâ„¢ stent | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| successful placement and retrieval without embolic occlusions of vessels distal to the position of the device | post-procedure | |
| overall survival rates | 1 month and 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eberhard Grube, MD | Herzzentrum Siegburg GMBH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Siegburg GMBH | Siegburg | 53721 | Germany |
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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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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| device evaluation |
| post-procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |