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

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

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 Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Device: Celect Platinum Vena Cava Filter

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

• Study Contact: Name: Sabina Andersen; Phone Number: +45 29 73 41 34; Email: sabina.hjorth@cookmedical.com

Study Locations

• Spain
  • Barcelona, Spain, 08907
    • Recruiting
    • Hospital Universitari de Bellvitage
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Reina Sofia de Cordoba
  • Sabadell, Spain, 08208
    • Recruiting
    • PARC Tauli
• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
  • Liverpool, United Kingdom, L7 8XP
    • Recruiting
    • Royal Liverpool Hospital
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
      • Recruiting
      • Leeds Teaching Hospital NHS Trust
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cook Research Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Celect Platinum Vena Cava Filter; Gunther Tulip Vena Cava Filter Retrieval Set
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Thrombosis; Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism
• Other Study ID Numbers: MDR-2126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No