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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05881798
• Other study ID #: MDR-2126
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: Cook Group Incorporated
• Contact: Cathrin Rogge
• Phone: +49 151 587 588 58
• Email: cathrin.rogge[@]cookmedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: January 2029
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Device:
• Celect Platinum Vena Cava Filter
Inferior vena cava filter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Filter Retrieval-related primary endpoint	Technical retrieval success, defined as endovascular retrieval of complete filter.	At the time of retrieval procedure