Pulmonary Thrombo-embolismNCT02674672
A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
A study testing VenaTech® (VenaTech Retrievable Filter) in people with Pulmonary Thrombo-embolism, run by B.Braun Médical - CoE Chasseneuil at 1 site in France.
Trial summary
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Thrombo-embolism
- What is being tested?
- VenaTech® (VenaTech Retrievable Filter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to May 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary thrombo-embolism with contraindication to anticoagulation.
- Failure of anticoagulant therapy in thrombo-embolic diseases.
- Prevention of pulmonary embolism in patients with a recent history ( <3 months) of DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary contra-indication to the use of therapeutic doses of anticoagulants.
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
Who cannot join
- The filter should not be implanted in patients with :
- A vena cava which has a diameter < 14 mm or > 28 mm (due to the risk of device migration)
- Risk of septic embolism
- Known allergy to the materials contained in the kit, allergy to contrast media.
- Severely disabled patients whose life-expectancy, up to 6 months, appears limited according to the investigator's opinion.
- In addition, exclusion criteria are also extended to :
Show all 12Show fewer
- Patients who cannot be regularly followed up by the participating center
- Subject who already has an implanted vena cava filter
- Subject who has a duplicated IVC
- Subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material
- Subject unable to understand information about participation in the study due to a language barrier, intellectual deficiency, psychiatric problems…
- Subject who has a renal failure (creatinemia clearance < 30ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter
- Conditions
- Pulmonary Thrombo-embolism
- Being tested
- VenaTech® (VenaTech Retrievable Filter)
- Keywords
- VenaTech® Retrievable Vena Cava Filter, safety, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenaTech® (VenaTech Retrievable Filter)Device
| Study group | Role | What they receive |
|---|---|---|
| VenaTech Retrievable arm | Experimental | VenaTech Retrievable arm Receives: Device: VenaTech® (VenaTech Retrievable Filter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Thrombo-embolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.Braun Médical - CoE Chasseneuil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674672
- Sponsor's protocol ID
- AAG-G-H-1419
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dean C, Kim YI, Sanchez O, Martelli N, Sapoval M, Pellerin O. Safety and efficacy of the VenaTech Retrievable inferior vena cava filter: a first-in-man single-center prospective study. CVIR Endovasc. 2022 Oct 4;5(1):50. doi: 10.1186/s42155-022-00325-y.
PubMed 36194306
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
- ClinicalTrials.gov ID
- NCT02674672
- Acronym / sponsor ID
- AAG-G-H-1419
- Conditions
- Pulmonary Thrombo-embolism
- Keywords
- VenaTech® Retrievable Vena Cava Filter, safety, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- B.Braun Médical - CoE ChasseneuilIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Feb 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.
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VenaTech Retrievable arm | Experimental | Device: VenaTech® (VenaTech Retrievable Filter)VenaTech Retrievable arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pulmonary thrombo-embolism with contraindication to anticoagulation.
- Failure of anticoagulant therapy in thrombo-embolic diseases.
- Prevention of pulmonary embolism in patients with a recent history ( <3 months) of DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary contra-indication to the use of therapeutic doses of anticoagulants.
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
Key exclusion criteria (12 listed)
- The filter should not be implanted in patients with :
- Patients who cannot be regularly followed up by the participating center
- Subject who already has an implanted vena cava filter
- Subject who has a duplicated IVC
- Subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material
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 |
|---|---|---|
| VenaTech® (VenaTech Retrievable Filter) | Device | VenaTech Retrievable arm |
Primary outcome
Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation
Time frame: 12 weeks
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 3 Feb 2021.
- Derived from this study: PubMed 36194306Dean C, Kim YI, Sanchez O, Martelli N, Sapoval M, Pellerin O. Safety and efficacy of the VenaTech Retrievable inferior vena cava filter: a first-in-man single-center prospective study. CVIR Endovasc. 2022 Oct 4;5(1):50. doi: 10.1186/s42155-022-00325-y.
- Individual participant dataSharing planned: Undecided
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Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VenaTech® (VenaTech Retrievable Filter) in people with Pulmonary Thrombo-embolism, run by B.Braun Médical - CoE Chasseneuil at 1 site in France.
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 5 inclusion and 12 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674672, which also lists 1 linked publication.
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 3 Feb 2021.