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CompletedNCT02757001REFiVeCUpdated May 4, 2020

Inferior Vena Cava Retrievable Filters: Spanish Register

An observational study in Vena Cava Filters, sponsored by Group of Research in Minimally Invasive Techniques. Completed at 6 sites in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-04.

Sponsored by Group of Research in Minimally Invasive Techniques · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Vena Cava Filters

Keywords

  • Retrievable Inferior Vena Cava Filters
  • Pulmonary Embolism
03

In context

Lead sponsor

Group of Research in Minimally Invasive Techniques is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Indicated inferior vena cava filter implantation
  • Signed informed consent

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • OtherInferior 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. Complications in retrieval

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

    Time frame: 12 months

  3. Overall adverse events

    Registry of adverse events from filter implantation until retrieval.

    Time frame: 12 months

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02757001
Lead sponsor
Group of Research in Minimally Invasive Techniques
Collaborators
SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)
Responsible party
Sponsor
First posted
Apr 29, 2016
Start date
Jun 2016
Primary completion
Jul 2019
Completion
Jul 2019
Last update
May 4, 2020

Study contacts

Miguel A De Gregorio, Ph.D.
principal investigator · Minimal Invasive Techniques Research Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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