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no patients have been enrolled. Study suspended due to change of sponsor priorities during COVID
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30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.
Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FRAME | Experimental | Vein graft to be treated with FRAME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FRAME | Device | External support for vein grafts in peripheral bypass surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lutheran Hospital of Indiana | Fort Wayne | Indiana | 46804 | United States | ||
| University of Maryland Baltimore |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |