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

Cook Group

Status: Enrolling

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis

Treatments: Device: Celect Platinum Vena Cava Filter

Study type: Observational

Funder types: Industry

Identifiers

NCT05881798

MDR-2126

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

82 participants in 1 patient group

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

Description:

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

Treatment:

Device: Celect Platinum Vena Cava Filter