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| Name | Class |
|---|---|
| Yale University | OTHER |
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The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Winsor Laser Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Winsor Laser Catheter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Freedom from Major Adverse Events (MAE) through hospital discharge:
| up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Procedural success defined as the percent of target lesions that achieve ≤30% residual stenosis at the completion of the procedure (laser atherectomy and any adjunctive treatment) as determined by an independent angiographic core lab. | During Interventional Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Mena, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiovascular Colombiano | MedellĂn | Colombia |
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