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

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Acute Limb Ischemia; DVT; Deep Vein Thrombosis Leg; Lower Extremity Acute Limb Ischemia; LE ALI; Chronic DVT of Lower Extremity; Acute DVT of Lower Extremity; Thrombus in the Peripheral Venous Vasculature; Venous Embolism of Lower Extremities (Diagnosis); Arterial Embolism and Thrombosis
• Intervention / Treatment: Device: Liberant Thrombectomy System

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Manasa Gudipally; Phone Number: 763-514-4000; Email: manasa.gudipally@medtronic.com
• Study Contact Backup: Name: Janki Shah; Email: janki.shah@medtronic.com

Study Locations

• United States
  • Florida
    • Naples, Florida, United States, 34108
      • Recruiting
      • Naples Comprehensive Health
      • Contact: Manasa Gudipally

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Liberant thrombectomy system is intended for use in adult patients with occluded peripheral arterial and venous vessels.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Device related Serious Adverse Event at 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	Index Procedure
Rate of technical success at 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	Index procedure
Rate of Procedural Success at 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	Index procedure

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: John R Laird Jr, MD, Medtronic Endovascular

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Vascular Diseases; Thrombectomy; Aspiration; Thrombosis; adverse events; Peripheral Arterial Disease; Peripheral Vascular Diseases; Venous Thrombosis; Mechanical Thrombectomy; Aspiration Thrombectomy; Arterial Occlusive Diseases; Percutaneous Mechanical Thrombectomy; Thrombus in Peripheral Arterial Systems; Excipio; Liberant Thrombectomy System; Thrombus in Peripheral Venous Systems
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Atherosclerosis; Arteriosclerosis; Pathological Conditions, Signs and Symptoms; Thrombosis; Venous Thrombosis; Disease; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: MDT25034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No patients will be engaged, and no medical records will be accessed or used. Individual HCP responses for each case will be aggregated into a final report.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No