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

Cook Research Incorporated82 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Deep Vein Thrombosis Venous Thromboembolism Pulmonary Embolism

Interventions

Celect Platinum Vena Cava FilterDEVICE

Inferior vena cava filter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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