Pulmonary EmbolismNCT01847196
Angel® Catheter Early Feasibility Clinical Study
A study testing Angel® Catheter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by BiO2 Medical at 4 sites in United States.
Trial summary
The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis. 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
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2013to Jun 2014
- 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
INCLUSION CRITERIA (Must Answer YES to all Inclusion Criteria):
- Subject or legally authorized representative is willing and able to provide written informed consent, AND
- Subject is 18 years or older, AND
- Subject is currently admitted OR to be admitted to the Intensive Care Unit (ICU) within ≤36 hours of screening, AND
- Subject has a clinical need for a Central Venous Catheter, and/or the subject has an existing Central Venous Catheter that has been in place for <36 hours before Angel® Catheter placement, AND
- Subject is considered at high risk for PE and meets ONE of the following criteria:
- Subject has multiple trauma with at least ONE of the following:
- Severe head injury
- Head injury with a long bone fracture
- Spinal cord injury with paraplegia or quadriplegia
- Multiple (≥2) long bone fractures
- Multiple (≥2) long bone fractures with pelvic fracture
- Pelvic fracture requiring open fixation
- Critically ill subject in the Intensive Care Unit with at least ONE of the following:
- Hemorrhagic or ischemic stroke
- Multiple organ failure
- Active or recent bleeding (within the past 2 weeks)
- Severe sepsis
- Lower extremity DVT
- Anticipated ventilator requirement of greater than one week
- Critically ill subject requiring temporary (≥48 hours) interruption of medical thromboprophylaxis (prophylactic anticoagulation)
EXCLUSION CRITERIA (Must Answer NO to All Exclusion Criteria):
- Subject is pregnant or lactating
- BMI = (Weight (lb) x 703)/(〖Height〗^2 (inches)) > 45; BMI may also be calculated at http://nhlbisupport.com/bmi/bminojs.htm
- Subject has a pre-existing IVC filter in place
- Subject is currently receiving prophylactic anticoagulation, other than aspirin or Plavix. Specifically, the subject is receiving any of the following medications: heparin, low molecular weight heparin, factor Xa inhibitors (i.e. xabans), Coumadin, and thrombin inhibitors.
- Subject has a diagnosis of pulmonary embolism
- Subject is participating in another clinical investigation
- Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
- 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 (including a history of thrombosis of venous system on side of proposed access)
- Anticipated survival ≤48 hours
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9158
University of Texas Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism
The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.
Read the detailed description
STUDY ENDPOINTS
- Primary Endpoints:
- Initial Insights into Safety
- Success in delivery, maintenance and removal of the Angel® Catheter.
- Incidence and seriousness of all adverse events.
- Incidence of device or procedure-related adverse events.
- Secondary Endpoints:
- Evaluation of the separate and combined functions of the IVC filter and the central venous catheter device.
- Evaluate investigative site's ability to comprehend the procedural steps (Per the Insertion Procedure, the Repositioning Procedure, and the Removal Procedure)
- Evaluate operator challenges with device use (human factors).
- Evaluate success and challenges encountered in conducting a pivotal trial in critically ill patient population - including but not limited to Informed Consent and enrollment.
ENROLLMENT AND SUBJECT SAMPLE SIZE
The study is expected to enroll up to 20 subjects in up to 4 US investigational sites with a goal for 10 evaluable subjects in whom Angel® Catheter placement has been attempted.
STUDY DURATION
The device is designed to be deployed for less than 30 days. After enrollment and Angel® Catheter placement, subjects will be followed daily through the post-removal, seven (7) day follow up or until hospital discharge, whichever occurs first.
- Being tested
- 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.
Angel® CatheterDevice
Also called Angel Catheter, 2011-0420
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). 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 device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Angel® Catheter | Experimental | All eligible subjects will receive an Angel® Catheter. Receives: Device: Angel® Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Occuring for All Evaluable Subjects
All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.
Measured: From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days
Secondary outcomes (1)
Device Performance
Measured: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: IDE approval received for larger Pivotal Study
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiO2 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Schreiber, MD, Principal investigator, Oregon Health and Science UniversityLarry Martin, MD, Principal investigator, University of Mississippi Medical CenterJohn Holcomb, MD, Principal investigator, The University of Texas Health Science Center, HoustonMichael Cripps, MD, Principal investigator, University of Texas Southwestern Medical Center (Dallas)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847196
- Sponsor's protocol ID
- QD-155
- Status last verified
- Aug 2015
- First submitted
- 2 May 2013
- Last updated
- 26 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT01847196
- Acronym / sponsor ID
- QD-155
- Keywords
- Pulmonary Embolism, PE, DVT, Deep Vein Thrombosis, VTE, Venous Thromboembolism, prophylaxis, thromboprophylaxis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDE approval received for larger Pivotal Study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BiO2 MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 May 2013 (estimated)
- Results
- Posted 14 Aug 2015
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 clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.
Detailed description
STUDY ENDPOINTS
- Primary Endpoints:
- Initial Insights into Safety
- Success in delivery, maintenance and removal of the Angel® Catheter.
- Incidence and seriousness of all adverse events.
- Incidence of device or procedure-related adverse events.
- Secondary Endpoints:
- Evaluation of the separate and combined functions of the IVC filter and the central venous catheter device.
- Evaluate investigative site's ability to comprehend the procedural steps (Per the Insertion Procedure, the Repositioning Procedure, and the Removal Procedure)
- Evaluate operator challenges with device use (human factors).
- Evaluate success and challenges encountered in conducting a pivotal trial in critically ill patient population - including but not limited to Informed Consent and enrollment.
ENROLLMENT AND SUBJECT SAMPLE SIZE
The study is expected to enroll up to 20 subjects in up to 4 US investigational sites with a goal for 10 evaluable subjects in whom Angel® Catheter placement has been attempted.
STUDY DURATION
The device is designed to be deployed for less than 30 days. After enrollment and Angel® Catheter placement, subjects will be followed daily through the post-removal, seven (7) day follow up or until hospital discharge, whichever occurs first.
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® 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
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® CatheterAlso: Angel Catheter, 2011-0420The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). 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 device is intended for short-term use (less than 30 days) and must be removed before hospital discharge. | Device | Angel® Catheter |
Primary outcome
Number of Adverse Events Occuring for All Evaluable Subjects
Time frame: From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days
All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.
1 secondary outcome
Device Performance
Time frame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pulmonary Embolism
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Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
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Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
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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.
Martin Schreiber, MD principal investigator
Oregon Health and Science University
Larry Martin, MD principal investigator
University of Mississippi Medical Center
John Holcomb, MD principal investigator
The University of Texas Health Science Center, Houston
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angel® Catheter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by BiO2 Medical at 4 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?
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: stopped early, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 14 Aug 2015). 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?
Number of Adverse Events Occuring for All Evaluable Subjects (time frame: From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 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 26 Aug 2015.