An observational study in Deep Vein Thrombosis, Venous Thromboembolism and Pulmonary Embolism, sponsored by Cook Research Incorporated. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Cook Research Incorporated (part of Cook Group Incorporated) · Observational
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.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 82 is below the median of 301 across 274 observational studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Device: Celect Platinum Vena Cava Filter
Inferior vena cava filter
Filter-related primary endpoint (safety)
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.
Time frame: Index procedure through 12-months post procedure
Filter-related primary endpoint (performance)
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.
Time frame: 12-months post procedure
Filter Retrieval-related primary endpoint
Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death.
Time frame: Through 30-days post procedure
Filter Retrieval-related primary endpoint
Technical retrieval success, defined as endovascular retrieval of complete filter.
Time frame: At the time of retrieval procedure
Plan to share: Undecided — Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Oct 2026, 16 months after the start.
Of 127 observational studies under Venous Thrombosis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 82. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
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