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NCT05600816
SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
Conditions: Peripheral Vascular Occlusive Disease
Sex: All
Phase: NA
Enrollment: 40
Sponsor: SurModics, Inc.
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).
Eligibility Criteria
Inclusion Criteria:Individuals aged 18 years or olderPatients 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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical carePatients who would likely experience benefit from mechanical thrombus removalExclusion Criteria:Presence of a stent in the target veinKnown aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C/S Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V LeidenLimb-threatening circulatory compromiseKnown symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunctionPatients with a positive COVID test result at the time of the procedurePatients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infectionHistory of, or active heparin induced thrombocytopenia (HIT)Inability to withstand endovascular proceduresLife expectancy < 1 yearParticipation in any other drug or device studies that have not reached the primary endpoint follow up, which could compromise the results of either trialPatient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocolLikely inability to comply with the protocol or cooperate fully with the investigator and site personnelKnown or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinionInability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)
Source: ClinicalTrials.gov (NCT05600816). StuddyBuddy aggregates publicly available trial information.