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

Recruiting

• Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism
• Interventions: Device: Celect Platinum Vena Cava Filter

• Registration Number: NCT05881798
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-05-31
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-02
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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-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 Retrieval-related primary endpoint	At the time of retrieval procedure	Technical retrieval success, defined as endovascular retrieval of complete filter.

Trial Locations

Locations (2)

Parc Tauli; 🇪🇸 Sabadell, Spain

Royal Liverpool Hospital; 🇬🇧 Liverpool, United Kingdom