Status:
TERMINATED
CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
Lead Sponsor:
Medtronic Endovascular
Conditions:
Observational Study
Eligibility:
All Genders
18+ years
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03869645
Start Date
June 1 2019
End Date
August 26 2020
Last Update
September 13 2022
Active Locations (3)
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1
Memorial Health Services
Fountain Valley, California, United States, 92708
2
St. Joseph Hospital
Orange, California, United States, 92868
3
University of Virginia
Charlottesville, Virginia, United States, 22903