Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Rate of Device related Serious Adverse Event at Index procedure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of Device related Serious Adverse Event at Index procedure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported