Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study

Study Overview
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Brief Summary
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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.

Official Title
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Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study

Conditions
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Deep Vein Thrombosis, Venous Thromboembolism, Pulmonary Embolism

Intervention / Treatment
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* Device: Celect Platinum Vena Cava Filter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients indicated for the placement of a Celect Platinum Vena Cava Filter<br>Patients indicated for the placement of a Celect Platinum Vena Cava Filter | Device: Celect Platinum Vena Cava Filter<br>* Inferior vena cava filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filter-related primary endpoint (safety) | 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. | Index procedure through 12-months post procedure | 
| Filter-related primary endpoint (performance) | 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. | 12-months post procedure | 
| Filter Retrieval-related primary endpoint | Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death. | Through 30-days post procedure | 
| Filter Retrieval-related primary endpoint | Technical retrieval success, defined as endovascular retrieval of complete filter. | At the time of retrieval procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celect Platinum Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set