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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-02

Study Completion Date

2030-12-31

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.

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Detailed Description

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Conditions

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Deep Vein Thrombosis Venous Thromboembolism Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients indicated for the placement of a Celect Platinum Vena Cava Filter

Celect Platinum Vena Cava Filter

Intervention Type DEVICE

Inferior vena cava filter

Interventions

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Celect Platinum Vena Cava Filter

Inferior vena cava filter

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No