Peripheral Vascular Occlusive DiseaseCHOMPNCT05600816
SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
A study testing Pounce Venous Thrombectomy System in people with Peripheral Vascular Occlusive Disease, run by SurModics, Inc..
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Vascular Occlusive Disease
- What is being tested?
- Pounce Venous Thrombectomy System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care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
Who cannot join
- 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
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- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- Peripheral Vascular Occlusive Disease
- Being tested
- Pounce Venous Thrombectomy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pounce Venous Thrombectomy SystemDevice
The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
| Study group | Role | What they receive |
|---|---|---|
| Pounce Venous Thrombectomy System | Other | Subjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System Receives: Device: Pounce Venous Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurModics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lichtenberg, MD, Principal investigator, Klinikum Hochsauerland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600816
- Sponsor's protocol ID
- SUR21-001
- Acronym
- CHOMP
- Status last verified
- May 2024
- First submitted
- 9 Feb 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOMP: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
- ClinicalTrials.gov ID
- NCT05600816
- Acronym / sponsor ID
- CHOMP / SUR21-001
- Conditions
- Peripheral Vascular Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SurModics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pounce Venous Thrombectomy System | Other | Device: Pounce Venous Thrombectomy SystemSubjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pounce Venous Thrombectomy SystemThe device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature. | Device | Pounce Venous Thrombectomy System |
Primary outcome
Device Performance
Time frame: 30 days, 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lichtenberg, MD principal investigator
Klinikum Hochsauerland GmbH
Questions about this trial
What is this clinical trial studying?
A study testing Pounce Venous Thrombectomy System in people with Peripheral Vascular Occlusive Disease, run by SurModics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nusrath Sultana, MD (763-777-2737, nsultana@surmodics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Performance (time frame: 30 days, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.