Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
Cook Research Incorporated
Summary
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed * Subject has not previously participated in the Cook MDR-2126 study. Exclusion Criteria: * Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
Interventions
- DeviceCelect Platinum Vena Cava Filter
Inferior vena cava filter
Locations (7)
- Cedars-Sinai Medical CenterLos Angeles, California
- Hospital Universitari de BellvitageBarcelona
- Hospital Reina Sofia de CordobaCórdoba
- Parc TauliSabadell
- Leeds Teaching Hospital NHS TrustLeeds, West Yorkshire
- Hull University Teaching Hospitals NHS TrustHull