Inferior Vena Cava Retrievable Filters: Spanish Register
REFiVeC
1 other identifier
observational
200
1 country
6
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedMay 4, 2020
July 1, 2019
3.1 years
April 26, 2016
April 30, 2020
Conditions
Keywords
Outcome Measures
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).
12 months
Secondary Outcomes (3)
Dwell time
12 months
Complications in retrieval
12 months
Overall adverse events
12 months
Interventions
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 Criteria
Patients in whom a vena cava filter has been implanted with intention of being retrieved (non-permanent).
You may qualify if:
- Indicated inferior vena cava filter implantation
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel A De Gregorio, Ph.D.
Minimal Invasive Techniques Research Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
April 29, 2016
Study Start
June 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
May 4, 2020
Record last verified: 2019-07