Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liberant Thrombectomy System.
- Who it may be relevant to
- Registry conditions: Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis, Acute DVT of Lower Extremity, Chronic DVT of Lower Extremity. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Liberant 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
Primary outcome measures
- Rate of Device related Serious Adverse Event at Index procedure [Time frame: Index Procedure]
- Rate of technical success at Index procedure [Time frame: Index procedure]
- Rate of Procedural Success at Index procedure [Time frame: Index procedure]
Eligibility 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:
- Patient treated is age ≥ 22 years at the time of procedure
- Use of Liberant in accordance with the device labeling within 72 hours of index procedure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- MedStar Health — Washington D.C.
- Naples Comprehensive Health — Naples
- Mount Sinai — New York
Identifiers
NCT: NCT07335341 · MDT25034