Observational Study Clinical Trial
Official title:
CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
NCT number | NCT03869645 |
Other study ID # | TP18-0009 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | August 26, 2020 |
Verified date | September 2022 |
Source | Medtronic Endovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 18 |
Est. completion date | August 26, 2020 |
Est. primary completion date | August 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
United States | Memorial Health Services | Fountain Valley | California |
United States | St. Joseph Hospital | Orange | California |
Lead Sponsor | Collaborator |
---|---|
Medtronic Endovascular |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Device Success | Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications | Day 0 | |
Secondary | Technical Success Rate | Ratio of successful thrombus removals and total number of participants | Day 0 | |
Secondary | Thrombus removal rate | percent of thrombus removal comparing pre-treatment to post-treatment venography | Day 0 | |
Secondary | 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 | |
Secondary | Safety Endpoint | Evaluation of the incidence of unanticipated adverse device events: estimated to be less than or equal to 5% | 30 days |
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