Acute DVT of Lower Extremity, Acute Limb Ischemia, Arterial Embolism and Thrombosis, Chronic DVT of Lower Extremity, Deep Vein Thrombosis Leg, DVT, LE ALI, Lower Extremity Acute Limb Ischemia, Peripheral Arterial Disease, Thrombus in the Peripheral Venous Vasculature, Venous Embolism of Lower Extremities (Diagnosis)
Conditions
Keywords
Thrombus in Peripheral Arterial Systems, Thrombectomy, Thrombosis, Venous Thrombosis, Aspiration Thrombectomy, Percutaneous Mechanical Thrombectomy, Arterial Occlusive Diseases, Vascular Diseases, Peripheral Vascular Diseases, Peripheral Arterial Disease, Mechanical Thrombectomy, Aspiration, Liberant Thrombectomy System, adverse events, Excipio, Thrombus in Peripheral Venous Systems
Brief summary
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ 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 Liberant™ thrombectomy system when used for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems
Detailed description
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.
Interventions
DEVICELiberant Thrombectomy System
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
Sponsors
Medtronic Endovascular
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient case selection to be included in the clinical assessment will be specific to Liberant and will be made according to the following criteria: 1. Patient treated is age ≥ 22 years at the time of procedure 2. Use of Liberant in accordance with the device labeling within 72 hours of index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device related Serious Adverse Event at Index procedure | 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 |
| Rate of technical success at Index procedure | 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 |
| Rate of Procedural Success at Index procedure | 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 |
Countries
United States
Contacts
CONTACTManasa Gudipally
CONTACTElizabeth Hunt
PRINCIPAL_INVESTIGATORJohn R Laird Jr, MD
Medtronic Endovascular
Outcome results
None listed