Pulmonary EmbolismPhase 1NCT01403090
Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism
A Phase 1 study testing Angel Catheter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by BiO2 Medical at 2 sites in Colombia.
Trial summary
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism
- What is being tested?
- Angel Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesColombia
- Study dates
- Dec 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is 18 years and older
- Be admitted to the hospital
- One of the following two criteria:
- Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria:
- Contraindications for anticoagulation
- Recurrent PE despite adequate anticoagulation
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- Emergency treatment following massive pulmonary embolism
- Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including:
- Patients with multiple trauma and active or recent bleeding with contraindications to anticoagulation or that require a temporary stop of anticoagulation
- severe head injury with coma
- severe hemorrhagic stroke with coma
- head injury with a long bone fracture
- spinal cord injury with paraplegia or quadriplegia
- multiple (≥2) long bone fractures with pelvic fracture
- multiple (≥4) long bone fractures
- Critically ill patients in the Medical or Surgical Intensive Care Unit with high risk of PE that require but are contraindicated for anticoagulation prophylaxis and will benefit from a temporary filter and a central venous access catheter
- Patients who had recently undergone or are about to undergo a surgical procedure that requires temporary interruption of anticoagulation for Venous Thromboembolism (VTE) and will benefit from a temporary vena cava filter and central
Who cannot join
- Patient is less than 18 years
- Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit
- Patient or next legal representative cannot give informed consent
- Patients with anticipated survival < 2 days (catastrophic illness)
- Body mass index greater than 35
- Patient has a pre-existing filter
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- Participation in another simultaneous interventional medical investigation or interventional trial.
- Patient has indications for a permanent filter at the time of the initial evaluation
- Patient has an uncontrollable coagulopathy with active bleeding.
- Patient with proven endocarditis or bacteremia
- Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol
- Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins
- Patient with functioning pelvic renal allograft on the only side available for device insertion
- Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Clinica las Americas
Medellín, Antioquia
Hospital Pablo Tobon Uribe
Medellín, Antioquia
About this study
Official title: A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter in Hospitalized Human Subjects With a Temporary Risk of Pulmonary Embolism
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .
- Being tested
- Angel Catheter
- Keywords
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism, Central Line Catheter, Vena Cava Filters
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angel CatheterDevice
The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Angel Catheter | Experimental | Not described Receives: Device: Angel Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiO2 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Cadavid, MD, Principal investigator, Hospital Pablo Tobon UribeBladimir Gil, MD, Principal investigator, Clinica Las Americas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403090
- Sponsor's protocol ID
- CPR-001
- Status last verified
- Apr 2013
- First submitted
- 25 Jul 2011
- Last updated
- 20 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter in Hospitalized Human Subjects With a Temporary Risk of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT01403090
- Acronym / sponsor ID
- CPR-001
- Keywords
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism, Central Line Catheter, Vena Cava Filters
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BiO2 MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Posted 20 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angel Catheter | Experimental | Device: Angel Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject is 18 years and older
- Be admitted to the hospital
- Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria:
- Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including:
Key exclusion criteria (14 listed)
- Patient is less than 18 years
- Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit
- Patient or next legal representative cannot give informed consent
- Patients with anticipated survival < 2 days (catastrophic illness)
- Body mass index greater than 35
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 |
|---|---|---|
| Angel CatheterThe Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin. | Device | Angel Catheter |
Primary outcome
Safety
Time frame: 30 days
Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carlos Cadavid, MD principal investigator
Hospital Pablo Tobon Uribe
Bladimir Gil, MD principal investigator
Clinica Las Americas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angel Catheter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by BiO2 Medical at 2 sites in Colombia.
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 17 inclusion and 14 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 30 days). 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 20 May 2013.