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The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberantâ„¢ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and performance of the Medtronic Liberantâ„¢ thrombectomy system when used for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems
The Liberant Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual case experience following routine utilization of Liberant in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural incidents of risk and evaluate device performance. At least 50 use cases will be collected and aggregated from at least 10 participating HCPs. This data collection is for a single point in time, with no patient follow-up. Individual HCP responses for each case will be aggregated by a third party vendor.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberant Thrombectomy System | Device | The Liberant thrombectomy system is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Device related Serious Adverse Event at Index procedure | An Adverse Event that converted to Serious Adverse Event, involving the function of the subject device, or the presence of the device in the body, including events that are directly attributable to the Liberant Thrombectomy System | Index Procedure |
| Rate of technical success at Index procedure | Technical success: Successful introduction, delivery, aspiration of fresh, soft emboli or thrombi, and retrieval of the Liberant per the Instructions for Use (IFU) during the index procedure | Index procedure |
| Rate of Procedural Success at Index procedure | Procedure success: Successful removal of fresh, soft emboli or thrombi and restoration of adequate blood flow, inclusive of all endovascular therapies during the index procedure | Index procedure |
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Patient case selection to be included in the clinical assessment will be specific to Liberant and will be made according to the following criteria:
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The Liberant thrombectomy system is intended for use in adult patients with occluded peripheral arterial and venous vessels.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manasa Gudipally | Contact | 763-514-4000 | manasa.gudipally@medtronic.com | |
| Elizabeth Hunt | Contact | elizabeth.m.hunt@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| John R Laird Jr, MD | Medtronic Endovascular | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health | Recruiting | Washington D.C. | District of Columbia | 003329 | United States |
No patients will be engaged, and no medical records will be accessed or used. Individual HCP responses for each case will be aggregated into a final report.
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| Naples Comprehensive Health | Recruiting | Naples | Florida | 34108 | United States |
|
| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| ID | Term |
|---|---|
| D004194 | Disease |
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| D058729 | Peripheral Arterial Disease |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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