SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSurModics, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pounce Venous Thrombectomy System
DeviceThe device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Pounce Venous Thrombectomy SystemOther 1 intervention
Trial outcomes
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.
Time frame
30 days, 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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