Pulmonary EmbolismNCT02420626
Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System
An observational study of Pulmonary Embolism and Venous Thromboembolism, run by Volcano Corporation at 3 sites in United States.
Trial summary
The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism, Deep Vein Thrombosis
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to May 2019
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are eligible for inclusion if they are scheduled for a vena cava filter implant with the Crux VCF System or have had a Crux VCF implanted within the previous 6 months for any of the following situations: 1. Pulmonary thromboembolism when anticoagulation therapy is contraindicated; 2. Failure of anticoagulation therapy in thromboembolic disease; 3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and 4. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Who may be able to join
- The patient is >18 years of age.
- Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.
- Scheduled for and receives a Crux VCF implant or;
- Have previously had a Crux VCF implanted within the previous 6 months.
Who cannot join
- Patient is scheduled for filter implant, but did not have a Crux VCF filter implanted due to anatomical exclusions or technical failures.
- Patients unwilling or unable to comply with the protocol and provide informed consent.
- Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
- Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northside Vascular Surgery
Atlanta, Georgia, 30342
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Rex Healthcare
Raleigh, North Carolina, 27607
About this study
Official title: Volcano Crux Vena Cava Filter Registry
The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.
Read the detailed description
The Crux VCF Registry is a non-randomized clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux VCF System. The registry includes consecutive patients treated with the Crux VCF in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. Patients may also be enrolled (roll-in) from a previous Crux VCF implant within the previous 6 months. Follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Pulmonary Embolism
The primary objective is to evaluate the long term clinical outcomes of patients treated with the Crux VCF for the prevention of PE over a two year period or up to filter retrieval, whichever comes first.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: An industry-wide, alternative, post-market study has been initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420626
- Sponsor's protocol ID
- 140203
- Status last verified
- Dec 2015
- First submitted
- 7 Apr 2015
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volcano Crux Vena Cava Filter Registry
- ClinicalTrials.gov ID
- NCT02420626
- Acronym / sponsor ID
- 140203
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: An industry-wide, alternative, post-market study has been initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 20 Apr 2015 (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.
The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.
Detailed description
The Crux VCF Registry is a non-randomized clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux VCF System. The registry includes consecutive patients treated with the Crux VCF in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. Patients may also be enrolled (roll-in) from a previous Crux VCF implant within the previous 6 months. Follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are eligible for inclusion if they are scheduled for a vena cava filter implant with the Crux VCF System or have had a Crux VCF implanted within the previous 6 months for any of the following situations: 1. Pulmonary thromboembolism when anticoagulation therapy is contraindicated; 2. Failure of anticoagulation therapy in thromboembolic disease; 3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and 4. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Key inclusion criteria (4 listed)
- The patient is >18 years of age.
- Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.
- Scheduled for and receives a Crux VCF implant or;
- Have previously had a Crux VCF implanted within the previous 6 months.
Key exclusion criteria (4 listed)
- Patient is scheduled for filter implant, but did not have a Crux VCF filter implanted due to anatomical exclusions or technical failures.
- Patients unwilling or unable to comply with the protocol and provide informed consent.
- Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
- Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevention of Pulmonary Embolism
Time frame: 2 years
The primary objective is to evaluate the long term clinical outcomes of patients treated with the Crux VCF for the prevention of PE over a two year period or up to filter retrieval, whichever comes first.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Venous Thromboembolism, run by Volcano Corporation at 3 sites in United States.
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 4 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: withdrawn, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Prevention of Pulmonary Embolism (time frame: 2 years). 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 22 Apr 2016.