Clinical trial NCT05600816: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
Official title: CHOMP: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Vascular Occlusive Disease
Lead sponsor: SurModics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care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

Primary outcomes:
measure: Device Performance
timeFrame: 30 days, 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Klinikum Hochsauerland GmbH
name: Michael Lichtenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: