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

NCT05881798 | Recruiting

• 1 other identifier: MDR-2126
• Study Type: observational
• Target: 82
• Locations: 3 countries
• Sites: 7

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.

Conditions

Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism

Keywords

Celect Platinum Vena Cava Filter; Gunther Tulip Vena Cava Filter Retrieval Set

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  Through 30-days post procedure

• Filter Retrieval-related primary endpoint

  Technical retrieval success, defined as endovascular retrieval of complete filter.

  At the time of retrieval procedure

Study Arms (1)

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

Interventions

Celect Platinum Vena Cava Filter DEVICE

Inferior vena cava filter

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• Subject has not previously participated in the Cook MDR-2126 study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (7)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Hospital Universitari de Bellvitage

Barcelona, 08907, Spain

RECRUITING

Hospital Reina Sofia de Cordoba

Córdoba, 14004, Spain

RECRUITING

Parc Tauli

Sabadell, 08208, Spain

RECRUITING

Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

Royal Liverpool Hospital

Liverpool, L7 8XP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Lung Diseases; Respiratory Tract Diseases; Embolism

Central Study Contacts

Sabina Andersen

CONTACT

+45 29 73 41 34; sabina.hjorth@cookmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 31, 2023
• Study Start: June 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

GB (3); ES (3); US (1)