Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Celect Platinum Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set
Brief 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.
Interventions
DEVICECelect Platinum Vena Cava Filter
Inferior vena cava filter
Sponsors
Cook Research Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filter-related primary endpoint (safety) | Index procedure through 12-months post procedure | Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (\>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death. |
| Filter-related primary endpoint (performance) | 12-months post procedure | Performance: Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration. |
| Filter Retrieval-related primary endpoint | Through 30-days post procedure | Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death. |
Countries
Spain, United Kingdom, United States
Contacts
CONTACTSabina Andersen
Outcome results
None listed