Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)

Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)

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).

Study Overview

• Status: Completed
• Conditions: Vena Cava Filters
• Intervention / Treatment: Other: Inferior vena cava filter placement and retrieval

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28023
    • Hospital Vithas Nisa Pardo de Aravaca
  • Málaga, Spain, 29010
    • Hospital Regional Carlos Haya
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega
  • Zaragoza, Spain, 50003
    • Lozano Blesa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in whom a vena cava filter has been implanted with intention of being retrieved (non-permanent).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications in retrieval	Difficulties in retrieval and complications at the time of retrieval will be specifically recorded.	12 months
Overall adverse events	Registry of adverse events from filter implantation until retrieval.	12 months

Collaborators and Investigators

• Sponsor: Group of Research in Minimally Invasive Techniques
• Collaborators: SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)
• Investigators: Principal Investigator: Miguel A De Gregorio, Ph.D., Minimal Invasive Techniques Research Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (ESTIMATE): April 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pulmonary Embolism; Retrievable Inferior Vena Cava Filters
• Other Study ID Numbers: GITMI