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The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patency of lower extremity vein bypass grafts | Primary patency of lower extremity vein bypass grafts at one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes | Device | Identify and validate intraoperative TTFM and HFUS findings (e.g. threshold values of Mean Graft Flow (MGF), MGF capacity, flow curve pattern, morphological issues) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary graft patency rate | Freedom from any repeat graft intervention, graft thrombosis, or clinically significant stenosis (>70% by either Duplex criteria or angiographic imaging) in the bypass | at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Limb-Threatening Ischemia patients scheduled to undergo a vein bypass with or without arterial inflow reconstruction to a below-knee and above ankle target
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Waaler | Contact | +4790892713 | anne.waaler@medistim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |