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The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.
Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serranator | Other |
| |
| POBA | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serranator | Device | Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of post treatment recoil | Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty. | 15 minutes post procedure |
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Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Giasolli | Contact | 610.688.2006 | rgiasolli@cagentvascular.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| POBA | Device | Plain balloon angioplasty device |
|
| Klinik für Angiologie, Klinikum Hochsauerland GmbH | Recruiting | Arnsberg | Germany |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |