Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCook Research Incorporated
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Celect Platinum Vena Cava Filter
DeviceInferior vena cava filter
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: Patients indicated for the placement of a Celect Platinum Vena Cava Filter1 intervention
Trial outcomes
Primary outcomes
1
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 procedure2
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 procedure3
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 procedure4
Filter Retrieval-related primary endpoint
Technical retrieval success, defined as endovascular retrieval of complete filter.
Time frame
At the time of retrieval procedureSponsors and contacts
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Source ClinicalTrials.gov