Pulmonary EmbolismNCT02917135
Angel® Catheter Post Market Registry
An observational study of Pulmonary Embolism and Medical Device Complication, run by BiO2 Medical at 5 sites in 3 countries.
Trial summary
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis
- What is being tested?
- Angel® Catheter
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2016to Jul 2018
- How long will I take part?
- 33 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry population will include all consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites.
Who may be able to join
- All consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place.
Who cannot join
- N/A
Trial locations and contacts
5 sites in 3 countries.
Luis Angel, MD contact
5 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Bremerhaven Reinkenheide Hospital
Bremersheide
Ruediger Dissmann, MD
Olaf Kuek, MD, olaf.kuek@klinikum-bremerhaven.de
- Recruiting
University of Mannheim
Mannheim
Ibrahim Akin, MD, ibrahim.akin@umm.de
Ibrahim Akin, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal London Hospital
London
Nicholas Bunker, MD, nicholas.bunker@bartshealth.nhs.uk
Nicholas Bunker, MD
- Recruiting
Royal Berkshire Hospital
Reading
Abby Brown, abby.brown@royalberkshire.nhs.uk
Carl Waldmann, MD
Italy1 site, 1 recruiting
- Recruiting
Ospendale Santa Maria di Loreto
Naples
Maurizio Postiglione, MD, mandizio@alice.it
Maurizio Postiglione, MD
About this study
Official title: European Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
Read the detailed description
The Registry population will include all consecutive patients in whom the Angel® Catheter is placed at participating sites. Information about the use of the catheter will be collected from placement through three days after device removal, or through death or discharge, whichever occurs first. Date of discharge/transfer from the Critical Care Unit will also be collected, completing the defined registry observation.
Information on up to 2,000 patients will be abstracted from a patient chart review. Sites will be asked to record data on all Angel® Catheter placements in their institution starting with their first Angel® Catheter placement after training by BiO2 Medical, Inc. personnel once all necessary institutional approvals are obtained confirming that Informed Consent is not required from the patient or LAR to collect, use, or publish patient data from this registry.
The registry population will include all consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites. The Instructions for Use (IFU) for the Angel® Catheter include the following indications:
- Pulmonary thromboembolism when anticoagulants are contraindicated; or
- Failure of anticoagulant therapy in thromboembolic diseases; or
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and or
- Critically ill patients at high risk of pulmonary embolism, not receiving medical thromboprophylaxis due to either increased risk of bleeding, active bleeding or heparin induced thrombocytopenia.
Since the Angel® Catheter is indicated for use in pregnant patients, patients who are pregnant may be included in this Registry after the proper risks and benefits have been assessed by the physician.
In summary, the Registry Event Schedule and data collection includes the following:
- Demographics and Current Medical Condition: Information collected to include demographics, medical condition and indication/s for use of the Angel® Catheter as recorded in the patient chart.
- Device Placement: Placement procedure data will be collected. If the catheter cannot be placed for some reason, no further follow up information will be collected on these patients.
- Angel® Catheter Indwelling experience: While the Angel® Catheter is in place during the patient's hospital stay, information regarding anticoagulation use (eCRF form #9), any complications, clinically significant PE, lower extremity DVT will be collected through three days after device retrieval, discharge from the hospital, or death, whichever occurs first.
- Device Retrieval: Information on ease of catheter retrieval and other key aspects will be collected.
- Registry Exit: Information about the patient's status at three days post device removal, death, or discharge from the hospital, whichever occurs first will be collected. The patient's date of discharge/transfer from the Critical Care Unit will also be collected.
- Anticoagulation Therapy: Information about the use of anticoagulation throughout the patient's observation period will be collected.
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis, Catheter-related Bloodstream Infection (CRBSI) Nos
- Being tested
- Angel® Catheter
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angel® CatheterDevice
The Angel® Catheter is a retrievable inferior vena cava (IVC) filter attached to a multi-lumen central venous access (CVC) catheter. The device is designed to be placed at the bedside 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 Angel® Catheter is intended for short-term (less than 30 days) vascular access via the femoral vein.
| Study group | Role | What they receive |
|---|---|---|
| Angel® Catheter | All consecutive, hospitalized patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites. Receives: Device: Angel® Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of averted PE
Measured: At the time of the pre-removal cavogram
Secondary outcomes (4)
Incidence and seriousness of all device-related adverse events
Measured: While the Angel Catheter is in place, including the insertion and removal procedures (Up to 30 days)
Incidence and seriousness of deep vein thrombosis
Measured: From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days)
Incidence and seriousness of catheter-related thrombosis
Measured: From device placement through removal (Up to 30 days)
Incidence and seriousness of clinically significant PE
Measured: From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
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 only
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 33 Days
Sponsor and investigators
- Lead sponsor
- BiO2 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Bunker, MD, Principal investigator, Royal London Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917135
- Sponsor's protocol ID
- QD-180
- Status last verified
- Oct 2016
- First submitted
- 23 Sep 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Angel® Catheter Post Market Registry
- ClinicalTrials.gov ID
- NCT02917135
- Acronym / sponsor ID
- QD-180
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis, Catheter-related Bloodstream Infection (CRBSI) Nos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- BiO2 MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Sep 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.
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
Detailed description
The Registry population will include all consecutive patients in whom the Angel® Catheter is placed at participating sites. Information about the use of the catheter will be collected from placement through three days after device removal, or through death or discharge, whichever occurs first. Date of discharge/transfer from the Critical Care Unit will also be collected, completing the defined registry observation.
Information on up to 2,000 patients will be abstracted from a patient chart review. Sites will be asked to record data on all Angel® Catheter placements in their institution starting with their first Angel® Catheter placement after training by BiO2 Medical, Inc. personnel once all necessary institutional approvals are obtained confirming that Informed Consent is not required from the patient or LAR to collect, use, or publish patient data from this registry.
The registry population will include all consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites. The Instructions for Use (IFU) for the Angel® Catheter include the following indications:
- Pulmonary thromboembolism when anticoagulants are contraindicated; or
- Failure of anticoagulant therapy in thromboembolic diseases; or
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and or
- Critically ill patients at high risk of pulmonary embolism, not receiving medical thromboprophylaxis due to either increased risk of bleeding, active bleeding or heparin induced thrombocytopenia.
Since the Angel® Catheter is indicated for use in pregnant patients, patients who are pregnant may be included in this Registry after the proper risks and benefits have been assessed by the physician.
In summary, the Registry Event Schedule and data collection includes the following:
- Demographics and Current Medical Condition: Information collected to include demographics, medical condition and indication/s for use of the Angel® Catheter as recorded in the patient chart.
- Device Placement: Placement procedure data will be collected. If the catheter cannot be placed for some reason, no further follow up information will be collected on these patients.
- Angel® Catheter Indwelling experience: While the Angel® Catheter is in place during the patient's hospital stay, information regarding anticoagulation use (eCRF form #9), any complications, clinically significant PE, lower extremity DVT will be collected through three days after device retrieval, discharge from the hospital, or death, whichever occurs first.
- Device Retrieval: Information on ease of catheter retrieval and other key aspects will be collected.
- Registry Exit: Information about the patient's status at three days post device removal, death, or discharge from the hospital, whichever occurs first will be collected. The patient's date of discharge/transfer from the Critical Care Unit will also be collected.
- Anticoagulation Therapy: Information about the use of anticoagulation throughout the patient's observation period will be collected.
Study design
- Observational model
- Case only
- Target follow-up
- 33 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angel® Catheter | – | Device: Angel® CatheterAll consecutive, hospitalized patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry population will include all consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites.
Key inclusion criteria (1 listed)
- All consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place.
Key exclusion criteria (1 listed)
- N/A
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 is a retrievable inferior vena cava (IVC) filter attached to a multi-lumen central venous access (CVC) catheter. The device is designed to be placed at the bedside 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 Angel® Catheter is intended for short-term (less than 30 days) vascular access via the femoral vein. | Device | Angel® Catheter |
Primary outcome
Rate of averted PE
Time frame: At the time of the pre-removal cavogram
4 secondary outcomes
Incidence and seriousness of all device-related adverse events
Time frame: While the Angel Catheter is in place, including the insertion and removal procedures (Up to 30 days)
Incidence and seriousness of deep vein thrombosis
Time frame: From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days)
Incidence and seriousness of catheter-related thrombosis
Time frame: From device placement through removal (Up to 30 days)
Incidence and seriousness of clinically significant PE
Time frame: From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- 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.
Luis Angel, MD contact
Nicholas Bunker, MD principal investigator
Royal London Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Medical Device Complication, run by BiO2 Medical at 5 sites in 3 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, United Kingdom, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vickie Arford, RN (720-833-5695, varford@bio2medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of averted PE (time frame: At the time of the pre-removal cavogram). 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 13 Dec 2016.