Inferior Vena Cava Retrievable Filters: Spanish Register

Group of Research in Minimally Invasive Techniques200 enrolled

Overview

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).

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

200

Conditions

Vena Cava Filters

Interventions

Inferior vena cava filter placement and retrievalOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

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

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

Complications in retrieval

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

Time frame: 12 months

Overall adverse events

Registry of adverse events from filter implantation until retrieval.

Time frame: 12 months

Data from ClinicalTrials.gov

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