Vena Cava FiltersREFiVeCNCT02757001
Inferior Vena Cava Retrievable Filters: Spanish Register
An observational study of Vena Cava Filters, run by Group of Research in Minimally Invasive Techniques at 6 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vena Cava Filters
- What is being tested?
- Inferior vena cava filter placement and retrieval
- How many people
- 200 participants
- Where
- 6 sitesSpain
- Study dates
- Jun 2016to Jul 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in whom a vena cava filter has been implanted with intention of being retrieved (non-permanent).
Who may be able to join
- Indicated inferior vena cava filter implantation
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital de Basurto
Bilbao, 48013
Hospital Universitario La Princesa
Madrid, 28006
Hospital Vithas Nisa Pardo de Aravaca
Madrid, 28023
Hospital Regional Carlos Haya
Málaga, 29010
Hospital Universitario Rio Hortega
Valladolid, 47012
Lozano Blesa University Hospital
Zaragoza, 50003
About this study
Official title: Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)
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.
- Conditions
- Vena Cava Filters
- Being tested
- Inferior vena cava filter placement and retrieval
- Keywords
- Retrievable Inferior Vena Cava Filters, Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
Complications in retrieval
Difficulties in retrieval and complications at the time of retrieval will be specifically recorded.
Measured: 12 months
Overall adverse events
Registry of adverse events from filter implantation until retrieval.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vena Cava FiltersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Group of Research in Minimally Invasive Techniques
- Sponsor type
- University, hospital or other
- Collaborators
- SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)
- Responsible party
- Sponsor
- Investigators
- Miguel A De Gregorio, Ph.D., Principal investigator, Minimal Invasive Techniques Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757001
- Sponsor's protocol ID
- GITMI
- Acronym
- REFiVeC
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2016
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)
- ClinicalTrials.gov ID
- NCT02757001
- Acronym / sponsor ID
- REFiVeC / GITMI
- Conditions
- Vena Cava Filters
- Keywords
- Retrievable Inferior Vena Cava Filters, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Group of Research in Minimally Invasive TechniquesUniversity, hospital or other
- Collaborators
- SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in whom a vena cava filter has been implanted with intention of being retrieved (non-permanent).
Key inclusion criteria (2 listed)
- Indicated inferior vena cava filter implantation
- Signed informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior vena cava filter placement and retrievalThere 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. | Other | – |
Primary outcome
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).
3 secondary outcomes
Dwell time
Time frame: 12 months
Complications in retrieval
Time frame: 12 months
Overall adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
Related trials for Vena Cava Filters
RecruitingObservational study
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Deep Vein Thrombosis, Venous Thromboembolism
Active, not recruiting
US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism
Pulmonary Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A De Gregorio, Ph.D. principal investigator
Minimal Invasive Techniques Research Group
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vena Cava Filters, run by Group of Research in Minimally Invasive Techniques at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of retrieval (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.