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Not yet recruiting NCT05600816

SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

No phase Interventional Peripheral Vascular Occlusive Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pounce Venous Thrombectomy System.
Who it may be relevant to
Registry conditions: Peripheral Vascular Occlusive Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Device Performance [Time frame: 30 days, 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05600816 · SUR21-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗