SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

NCT05600816 | Not Yet Recruiting

• 1 other identifier: SUR21-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Peripheral Vascular Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Device Performance

  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.

  30 days, 1 year

Study Arms (1)

Pounce Venous Thrombectomy System

OTHER

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

Device: Pounce Venous Thrombectomy System

Interventions

Pounce Venous Thrombectomy System DEVICE

The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

Pounce Venous Thrombectomy System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care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

You may not qualify if:

• Presence of a stent in the target vein
• Known aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C/S Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V Leiden
• Limb-threatening circulatory compromise
• Known symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunction
• Patients with a positive COVID test result at the time of the procedure
• Patients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infection
• History of, or active heparin induced thrombocytopenia (HIT)
• Inability to withstand endovascular procedures
• Life expectancy \< 1 year
• 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
• Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
• Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
• Known or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinion
• Inability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)

Sponsors & Collaborators

• SurModics, Inc.: lead

Study Officials

• Michael Lichtenberg, MD

  Klinikum Hochsauerland GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nusrath Sultana, MD

CONTACT

763-777-2737; nsultana@surmodics.com

Aliza Avalos

CONTACT

209-485-2072; aavalos@surmodics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: November 1, 2022
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05