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Bayer terminated the program and sold the IP to Medronic
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To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cotavance | Experimental |
| |
| Standard balloon angioplasty | Active Comparator | POBA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cotavance Paclitaxel Coated Balloon | Device |
|
| |
| Standard balloon angioplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate procedural safety | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Identify and characterize therapeutic and functional endpoint assessments | 5 years |
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Inclusion Criteria:
- Subjects with CLI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University | Graz | Austria | ||||
| AZ St.-Blasius Hospital |
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| Device |
|
|
| Dendermonde |
| Belgium |
| University Hospital | Ghent | Belgium |
| University Hospital | Bern | Switzerland |
| University Hospital | Zurich | Switzerland |
| St. George's Hospital | London | United Kingdom |