Pulmonary EmbolismNCT02186223
The Angel® Catheter Pivotal Clinical Trial
A study testing The Angel® Catheter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by BiO2 Medical at 21 sites in United States.
Trial summary
The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation). 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?
- The Angel® Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- 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 or legally authorized representative is willing and able to provide written informed consent,
- Subject is 18 years or older,
- Subject is expected to remain in a critical care setting for at least 72 hours,
- AND at least one of the following inclusion criteria (4,5, and/or 6)
- Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:
- Active bleeding or at high risk for bleeding OR
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- Hypersensitivity to pharmacological thromboprophylaxis OR
- History of severe heparin induced thrombocytopenia OR
- Severe thrombocytopenia
- Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
- Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
Who cannot join
- Subject is pregnant
- Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
- Subject has a pre-existing IVC filter in place
- BMI = > 45
- Subject has functioning pelvic renal allograft on the only side available for device insertion
- Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
- Anatomic inability to place the Angel® Catheter
- Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of New Mexico Health
Albuquerque, New Mexico, 87106
University of Maryland Medical Center
Baltimore, Maryland, 21201
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Cooper University Hospital
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
Delray Medical Center
Delray Beach, Florida, 33483
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
John Peter Smith Health Network
Fort Worth, Texas, 76104
UF Health Shands Cancer Hospital
Gainesville, Florida, 32608
Ben Taub Hospital
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical Center of the Rockies
Loveland, Colorado, 80538
Regional One Health
Memphis, Tennessee, 38103
Jackson Memorial Hospital
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Hospital
New York, New York, 10029
University of Texas Health Science Center
San Antonio, Texas, 78229
UC San Diego Medical Center
San Diego, California, 92103
Mercy Hospital St. Louis
St Louis, Missouri, 63141
St. Mary's Medical Center
West Palm Beach, Florida, 33407
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
- Being tested
- The Angel® Catheter
- Keywords
- Pulmonary Embolism, PE, DVT, Deep Vein Thrombosis, VTE, Venous Thromboembolism, prophylaxis, thromboprophylaxis, contraindications to thromboprophylaxis, prophylactic, prevention, Inferior vena cava filter, IVC filter, filter, prevention of pulmonary embolism, trauma, critically-ill
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Venous Thromboembolism, Wounds and Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Angel® CatheterDevice
The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
| Study group | Role | What they receive |
|---|---|---|
| The Angel® Catheter | Experimental | All eligible subjects will receive an Angel® Catheter. Receives: Device: The Angel® Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
- Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.
- Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
Measured: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
Secondary outcomes (5)
Incidence of Acute Proximal Deep Vein Thrombosis
Measured: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Catheter Related Thrombosis
Measured: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Catheter Related Blood Stream Infections
Measured: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Major Bleeding Event
Measured: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of PEs Averted
During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.
Measured: During the pre-removal cavogram (An average of 6.8 days after device insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiO2 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CardioMed Device Consultants, LLC, Intrinsic Imaging, LLC, Novella Clinical
- Responsible party
- Sponsor
- Investigators
- Victor Tapson, MD, Principal investigator, Cedars Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186223
- Sponsor's protocol ID
- QD-230
- Status last verified
- Feb 2017
- First submitted
- 7 Jul 2014
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
- ClinicalTrials.gov ID
- NCT02186223
- Acronym / sponsor ID
- QD-230
- Keywords
- Pulmonary Embolism, PE, DVT, Deep Vein Thrombosis, VTE, Venous Thromboembolism, prophylaxis, thromboprophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- BiO2 MedicalIndustry (pharma, biotech, devices)
- Collaborators
- CardioMed Device Consultants, LLC, Intrinsic Imaging, LLC, Novella Clinical
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Angel® Catheter | Experimental | Device: The Angel® CatheterAll eligible subjects will receive an Angel® Catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject or legally authorized representative is willing and able to provide written informed consent,
- Subject is 18 years or older,
- Subject is expected to remain in a critical care setting for at least 72 hours,
- AND at least one of the following inclusion criteria (4,5, and/or 6)
- Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:
Key exclusion criteria (8 listed)
- Subject is pregnant
- Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
- Subject has a pre-existing IVC filter in place
- BMI = > 45
- Subject has functioning pelvic renal allograft on the only side available for device insertion
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 |
|---|---|---|
| The Angel® CatheterThe Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein. | Device | The Angel® Catheter |
Primary outcome
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
5 secondary outcomes
Incidence of Acute Proximal Deep Vein Thrombosis
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Catheter Related Thrombosis
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Catheter Related Blood Stream Infections
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Major Bleeding Event
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of PEs Averted
Time frame: During the pre-removal cavogram (An average of 6.8 days after device insertion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Victor Tapson, MD principal investigator
Cedars Sinai
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Angel® Catheter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by BiO2 Medical at 21 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 11 inclusion and 8 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). 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?
Freedom From Clinically Significant PE or Fatal PE During Treatment Period (time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 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 4 Apr 2017.