Observational Study
Conditions
Brief summary
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
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).
Interventions
Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System
Sponsors
Medtronic Endovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of blood flow | Day 0 - Intervention | Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Day 0 | Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications |
| Technical Success Rate | Day 0 | Ratio of successful thrombus removals and total number of participants |
| Thrombus removal rate | Day 0 | percent of thrombus removal comparing pre-treatment to post-treatment venography |
| VEINES Survey | </= Day 0 and Day 30 | 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. |
| Safety Endpoint | 30 days | Evaluation of the incidence of unanticipated adverse device events: estimated to be less than or equal to 5% |
Countries
United States
Outcome results
None listed