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Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study

This study is observing the Celect Platinum Vena Cava Filter and the Günther Tulip Vena Cava Filter Retrieval Set. These devices are used for conditions like deep vein thrombosis (blood clots in deep veins) and pulmonary embolism (blood clots in the lungs). The study aims to confirm that these devices continue to be safe and work well over time, and that their benefits outweigh any risks. Researchers will also look at how patients do for up to 5 years while the filter is in place. You may be able to join if you are 18 or older and are having a Celect Platinum Vena Cava Filter placed. This is an observational study, meaning researchers are watching what happens to patients who already receive these devices as part of their care. The study status is currently unclear.

Study design
This is an observational study that plans to include 82 participants. It is designed to collect information on patients who receive the Celect Platinum Vena Cava Filter.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for safety for up to 12 months after the filter is placed. Performance of the filter will be assessed at 12 months, and retrieval outcomes will be assessed up to 30 days after retrieval.

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NCT05881798

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

Recruiting
Not specifiedAges 18+Observational
Cook Research Incorporated
~82 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Celect Platinum Vena Cava Filter

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Filter-related primary endpoint (safety)
Measured over Index procedure through 12-months post procedure
+3 more outcomes measured

Conditions

Deep Vein Thrombosis
Venous Thromboembolism
Pulmonary Embolism

Explore related trials

Deep Vein ThrombosisPulmonary EmbolismVenous Thromboembolism

Where it's being run

7 sites across 4 states
Spain3
United Kingdom2
California1
West Yorkshire1

Who to contact

Sabina Andersen
[email protected]
+45 29 73 41 34
Email the study team

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Eligibility criteria

Inclusion

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

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 this trial measures

  • 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 endpointThrough 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.

  • Filter Retrieval-related primary endpointAt the time of retrieval procedure

    Technical retrieval success, defined as endovascular retrieval of complete filter.