Recruiting

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

Sponsor:

Cook Research Incorporated

Code:

NCT05881798

Conditions

Deep Vein Thrombosis

Venous Thromboembolism

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Celect Platinum Vena Cava Filter

Study Details

Brief 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.

Conditions

Deep Vein Thrombosis

Venous Thromboembolism

Pulmonary Embolism

Study ID

NCT05881798

Start date

Jun 2, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

82 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Celect Platinum Vena Cava Filter

Inferior vena cava filter

Primary outcome measure

Filter-related primary endpoint (safety) [ Time Frame: Index procedure through 12-months post procedure ]
Filter-related primary endpoint (performance) [ Time Frame: 12-months post procedure ]
Filter Retrieval-related primary endpoint [ Time Frame: Through 30-days post procedure ]
Filter Retrieval-related primary endpoint [ Time Frame: At the time of retrieval procedure ]

Central Contacts and Locations

Central contacts

Sabina Andersen

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

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

More Information

Sponsor

Cook Research Incorporated

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

Celect Platinum Vena Cava Filter
Gunther Tulip Vena Cava Filter Retrieval Set

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cook Research Incorporated on 2026-04-17.