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Due to safety concerns
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| Name | Class |
|---|---|
| W.L.Gore & Associates | INDUSTRY |
| Spectranetics Corporation | INDUSTRY |
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A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectranetics Laser plus Gore Viabahn Endoprosthesis | Other | Spectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface | Device | treatment for superficial femoral artery instent re-stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure. | 12 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Das, MD | Presbyterian Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gary Ansel, MD | Columbus | Ohio | 43214 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 24, 2015 | |
| Reset | Sep 23, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 24, 2015 | Sep 23, 2015 |