Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System

Medtronic

Status: Not yet enrolling

Conditions: Acute DVT of Lower Extremity; Thrombus in the Peripheral Venous Vasculature; Venous Embolism of Lower Extremities (Diagnosis); LE ALI; Deep Vein Thrombosis Leg; Chronic DVT of Lower Extremity; Arterial Embolism and Thrombosis; Lower Extremity Acute Limb Ischemia; Peripheral Arterial Disease; DVT; Acute Limb Ischemia

Treatments: Device: Liberant Thrombectomy System

Study type: Observational

Funder types: Industry

Identifiers

NCT07335341

MDT25034

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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