Inferior Vena Cava Retrievable Filters: Spanish Register

Vena Cava Filters Clinical Trial

— REFiVeC  

Official title:

Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757001
• Other study ID #: GITMI
• Status: Completed
• Start date: June 2016
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Group of Research in Minimally Invasive Techniques
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Spanish registry of retrievable vena cava filters.

This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).

A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

Description:

This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved.

Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved (dwell time), if retrieval is possible or not, and if there is any complication at the retrieval of the filter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Indicated inferior vena cava filter implantation

• Signed informed consent

Exclusion Criteria:

• Permanent filters (including retrievable filters intended to be used as permanent ones)

• Impossibility of follow-up (3, 6 and 12 months)

• Life expectancy less than a year

• Patient refusal to be included in the study, at any time

Related Conditions & MeSH terms

• Vena Cava Filters

Intervention

Other:
• Inferior vena cava filter placement and retrieval
There are really no interventions in this study. This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved. Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved, and if there is any complication at the retrieval of the filter.

Locations

Country	Name	City	State
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Vithas Nisa Pardo de Aravaca	Madrid
Spain	Hospital Regional Carlos Haya	Málaga
Spain	Hospital Universitario Rio Hortega	Valladolid
Spain	Lozano Blesa University Hospital	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Group of Research in Minimally Invasive Techniques	SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of retrieval	The primary outcome of this study is to verify if the filter can be retrieved on the scheduled day of retrieval (yes/no).	12 months
Secondary	Dwell time	Final dwell time of the filter (number of days from implantation to retrieval). It will be compared to the expected dwell time at the time of implantation.	12 months
Secondary	Complications in retrieval	Difficulties in retrieval and complications at the time of retrieval will be specifically recorded.	12 months
Secondary	Overall adverse events	Registry of adverse events from filter implantation until retrieval.	12 months