CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

Study Overview
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Brief Summary
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A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.

Detailed Description
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A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System. Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).

Official Title
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CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

Conditions
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Observational Study

Intervention / Treatment
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* Device: CAPERE Thrombectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are greater than or equal to 18 years of age Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms < 14 days Patients cleared medically for invasive endovenous procedures Exclusion Criteria: Patients with IVC filter in area to be treated Patients who are < 18 years of age. Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention Female who is pregnant or nursing Concurrent participation in another investigational drug or device treatment study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CAPERE Thrombectomy System|Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of blood flow | Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure | Day 0 - Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications | Day 0 | 
| Technical Success Rate | Ratio of successful thrombus removals and total number of participants | Day 0 | 
| Thrombus removal rate | percent of thrombus removal comparing pre-treatment to post-treatment venography | Day 0 | 
| VEINES Survey | Evaluation of quality of life (QoL) before and after treatment based on VEINES survey responses. Eight (8) QoL questions related to the patient's leg problems are evaluated and their scores aggregated into a single QoL score. The resultant aggregated QoL range is from 26 - 108 where the higher the number the higher the quality of life. | </= Day 0 and Day 30 | 
| Safety Endpoint | Evaluation of the incidence of unanticipated adverse device events: estimated to be less than or equal to 5% | 30 days |