SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

Not Applicable

Not yet recruiting

• Conditions: Peripheral Vascular Occlusive Disease
• Interventions: Device: Pounce Venous Thrombectomy System

• Registration Number: NCT05600816
• Lead Sponsor: SurModics, Inc.

Brief Summary

This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).

Detailed Description

This PMCF study is designed to further evaluate the safety and performance of the POUNCE Venous Thrombectomy system in the treatment of patients with symptomatic peripheral vascular thrombus through removal of thrombus. The study will collect both qualitative and quantitative data recorded by the investigators during the procedure to further evaluate safety and performance of the device.

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Study Start: 2025-04-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Individuals aged 18 years or older
2. Patients with peripheral vascular thrombus (e.g., iliofemoral) as confirmed by Doppler Ultrasonography (DUS)
3. Voluntary informed written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care
4. Patients who would likely experience benefit from mechanical thrombus removal

Exclusion Criteria

1. Presence of a stent in the target vein
2. Known aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C/S Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V Leiden
3. Limb-threatening circulatory compromise
4. Known symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunction
5. Patients with a positive COVID test result at the time of the procedure
6. Patients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infection
7. History of, or active heparin induced thrombocytopenia (HIT)
8. Inability to withstand endovascular procedures
9. Life expectancy < 1 year
10. Participation in any other drug or device studies that have not reached the primary endpoint follow up, which could compromise the results of either trial
11. Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
12. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
13. Known or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinion
14. Inability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pounce Venous Thrombectomy System	Pounce Venous Thrombectomy System	Subjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System

Primary Outcome Measures

Name	Time	Method
Device Performance	30 days, 1 year	Successful preparation and use of the device to achieve flow restoration, i.e., elimination of a minimum of 50% thrombus (SIR Grade II or Grade III) in the treated target venous segment.