SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study (CHOMP)

CHOMP: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Vascular Occlusive Disease
• Intervention / Treatment: Device: Pounce Venous Thrombectomy System

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nusrath Sultana, MD; Phone Number: 763-777-2737; Email: nsultana@surmodics.com
• Study Contact Backup: Name: Aliza Avalos; Phone Number: 209-485-2072; Email: aavalos@surmodics.com

Participation Criteria

Eligibility Criteria

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

Description

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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pounce Venous Thrombectomy System; Subjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System	Device: Pounce Venous Thrombectomy System; The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SurModics, Inc.
• Investigators: Principal Investigator: Michael Lichtenberg, MD, Klinikum Hochsauerland GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SUR21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No