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TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serrantor | Active Comparator | Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon |
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| PTA | Active Comparator | Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serranator PTA Serration Catheter | Device | The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Lumen Volume Stenosis | Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| OCT Residual Diameter Stenosis | Residual stenosis as measured by OCT | Baseline |
| Angiography Residual Diameter Stenosis | Residual stenosis as measured by angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feeny | Contact | 4197878496 | kjclinconsulting@gmail.com | |
| Wittwer | Contact | twittwer@mededge.io |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | Recruiting | New York | New York | 10032 | 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| PTA (Standard of Care) | Drug | A percutaneous transluminal angioplasty catheter will be used to treat the target lesion. |
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| Baseline |
| Dissection Pattern | The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration. | Baseline |
| Correlation of Luminal Gain and Plaque Modification | The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab. | Baseline |
| Rate of Optimal PTA | Rate of procedures that achieve optimal PTA (<30% diameter stenosis without flow-limiting dissection measured by angiography) | Baseline |
| Bail-out Stenting | Rate of bail-out stenting | Baseline |
| Weill Cornell Medical | Recruiting | New York | New York | 10065 | United States |
|
| 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 |