Inferior Vena Cava Retrievable Filters: Spanish Register

NCT ID: NCT02757001

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Vena Cava Filters

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)

UNKNOWN

Sponsor Role collaborator

Group of Research in Minimally Invasive Techniques

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel A De Gregorio, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Minimal Invasive Techniques Research Group

Locations

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Hospital de Basurto

Bilbao, , Spain

Site Status

Hospital Universitario La Princesa

Madrid, , Spain

Site Status

Hospital Vithas Nisa Pardo de Aravaca

Madrid, , Spain

Site Status

Hospital Regional Carlos Haya

Málaga, , Spain

Site Status

Hospital Universitario Rio Hortega

Valladolid, , Spain

Site Status

Lozano Blesa University Hospital

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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GITMI

Identifier Type: -

Identifier Source: org_study_id

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