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NCT Number: NCT05881798

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

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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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari de Bellvitage, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celect Platinum Vena Cava Filter

Device

Inferior vena cava filter

Primary outcomes

  1. Filter-related primary endpoint (safety)

    Time frame: 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.

  2. Filter-related primary endpoint (performance)

    Time frame: 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.

  3. Filter Retrieval-related primary endpoint

    Time frame: Through 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.

  4. Filter Retrieval-related primary endpoint

    Time frame: At the time of retrieval procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sabina Andersen

CONTACT

[email protected]

+45 29 73 41 34

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
May 31, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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