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NCT05881798Recruiting

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

Cook Research Incorporated

Start Date

6/2/2025

Completion Date

12/1/2030

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 Criteria

Age Range: 18 years to No maximum

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

DEVICE

Celect Platinum Vena Cava Filter

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Conditions

Deep Vein ThrombosisVenous ThromboembolismPulmonary Embolism

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Hospital Universitari de Bellvitage

Barcelona, 08907

Spain

Hospital Reina Sofia de Cordoba

Córdoba, 14004

Spain

Parc Tauli

Sabadell, 08208

Spain

Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire LS1 3EX

United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ

United Kingdom

Royal Liverpool Hospital

Liverpool, L7 8XP

United Kingdom