RecruitingNot Applicable

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

United States, Spain, United Kingdom82 participantsStarted 2025-06-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Filter-related primary endpoint (safety)

Timeframe: Index procedure through 12-months post procedure

Filter-related primary endpoint (performance)

Timeframe: 12-months post procedure

Filter Retrieval-related primary endpoint

Timeframe: Through 30-days post procedure

Filter Retrieval-related primary endpoint

Timeframe: At the time of retrieval procedure

Trial details

NCT IDNCT05881798

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10

Contact for this trial

Sabina Andersen

+45 29 73 41 34 sabina.hjorth@cookmedical.com

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