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

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05881798

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis Venous Thromboembolism Pulmonary Embolism	Device: Celect Platinum Vena Cava Filter

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

82 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients indicated for the placement of a Celect Platinum Vena Cava Filter Patients indicated for the placement of a Celect Platinum Vena Cava Filter	Device: Celect Platinum Vena Cava Filter Inferior vena cava filter

Arm

Intervention/Treatment

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

Device: Celect Platinum Vena Cava Filter

Inferior vena cava filter

Outcome Measures

Primary Outcome Measures

Filter-related primary endpoint (safety) [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.
Filter-related primary endpoint (performance) [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.
Filter Retrieval-related primary endpoint [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.
Filter Retrieval-related primary endpoint [At the time of retrieval procedure]
Technical retrieval success, defined as endovascular retrieval of complete filter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.