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Completed

NCT Number: NCT02757001

Inferior Vena Cava Retrievable Filters: Spanish Register

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).

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Key information

Conditions

Vena Cava Filters Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Basurto, Bilbao, Spain

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About 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 (dwell time), if retrieval is possible or not, and if there is any complication at the retrieval of the filter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inferior vena cava filter placement and retrieval

Other

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.

Primary outcomes

  1. Success of retrieval

    Time frame: 12 months

    The primary outcome of this study is to verify if the filter can be retrieved on the scheduled day of retrieval (yes/no).

Secondary outcomes

  1. Dwell time

    Time frame: 12 months

    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.

  2. Complications in retrieval

    Time frame: 12 months

    Difficulties in retrieval and complications at the time of retrieval will be specifically recorded.

  3. Overall adverse events

    Time frame: 12 months

    Registry of adverse events from filter implantation until retrieval.

Sponsors and collaborators

Lead sponsor

Group of Research in Minimally Invasive Techniques

Other

Collaborators

  • SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)

Registry information

Official study title

Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)

Acronym: REFiVeC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2016
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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