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Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTO Crossing and Percutaneous transluminal angioplasty | Device | Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Patients with a Major Adverse Events (MAE) | MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication. | 30 Day |
| Incidence of Intraprocedural Technical Success | Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO | Intraprocedural (<24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William A Gray, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Medical Center | Phoenix | Arizona | United States | |||
| University of Southern California Medical Center |
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| Los Angeles |
| California |
| United States |
| Torrance Memorial Medical Center | Torrance | California | United States |
| University of Colorado Denver | Denver | Colorado | United States |
| Emory University Medical Center | Atlanta | Georgia | United States |
| Prairie Cardiovascular Consultants | Springfield | Illinois | 62701 | United States |
| Columbia University Medical Center | New York | New York | United States |
| Wake Heart Center | Raleigh | North Carolina | United States |
| Dallas VA Medical Center | Dallas | Texas | United States |
| St. Joseph Hospital | Bellingham | Washington | United States |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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