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

ConditionsVenous Embolism of Lower Extremities (Diagnosis)Arterial Embolism and ThrombosisAcute DVT of Lower ExtremityChronic DVT of Lower ExtremityDVTDeep Vein Thrombosis LegThrombus in the Peripheral Venous VasculaturePeripheral Arterial DiseaseAcute Limb IschemiaLower Extremity Acute Limb IschemiaLE ALI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorMedtronic Endovascular

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Liberant Thrombectomy System

    Device

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Index Procedure
2

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

Time frame
Index procedure
3

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

Time frame
Index procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Endovascular

Lead sponsor

Source ClinicalTrials.gov
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