Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2016-07-31
2018-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
Study Groups
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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.
Angel® Catheter
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.
Interventions
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Angel® Catheter
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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BiO2 Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Bunker, MD
Role: PRINCIPAL_INVESTIGATOR
Royal London Hospital
Locations
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Bremerhaven Reinkenheide Hospital
Bremersheide, , Germany
University of Mannheim
Mannheim, , Germany
Ospendale Santa Maria di Loreto
Napoli, , Italy
Royal London Hospital
London, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ruediger Dissmann, MD
Role: primary
Olaf Kuek, MD
Role: backup
Ibrahim Akin, MD
Role: primary
Maurizio Postiglione, MD
Role: primary
Nicholas Bunker, MD
Role: primary
Abby Brown
Role: primary
Other Identifiers
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QD-180
Identifier Type: -
Identifier Source: org_study_id