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| Name | Class |
|---|---|
| BridgePoint Medical | INDUSTRY |
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This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).
The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BridgePoint Medial System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) | Device | Revascularization of coronary artery chronic total occlusion. Use of the BridgePoint Medical System to cross coronary CTOs prior to definitive revascularization treatment via angioplasty and/or stent implant |
| Measure | Description | Time Frame |
|---|---|---|
| CTO Crossing Rate | Peri-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | 30 days | |
| Perforation rate | Peri-procedural | |
| Acute myocardial infarction (AMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horst Sievert, MD | CardioVascular Center Frankfurt, St. Katharinen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Taunus Hospital | Bad Soden | Germany | ||||
| Klinikum Darmstadt |
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|
| Peri-procedural |
| Darmstadt |
| Germany |
| CardioVascular Center Frankfurt, St. Katharinen Hospital | Frankfurt | Germany |
| Universitäres Herz- und Gefässzentrum Hamburg | Hamburg | Germany |
| 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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