Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
Purpose
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
Conditions
- Venous Embolism of Lower Extremities (Diagnosis)
- Arterial Embolism and Thrombosis
- Acute DVT of Lower Extremity
- Chronic DVT of Lower Extremity
- DVT
- Deep Vein Thrombosis Leg
- Thrombus in the Peripheral Venous Vasculature
- Peripheral Arterial Disease
- Acute Limb Ischemia
- Lower Extremity Acute Limb Ischemia
- LE ALI
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
Naples, Florida 34108
Manasa Gudipally
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Endovascular
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.