Angel® Catheter Post Market Registry

Pulmonary Embolism Clinical Trial

Official title:

European Angel® Catheter Post Market Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917135
• Other study ID #: QD-180
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: December 12, 2016
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2016
• Source: BiO2 Medical
• Contact: Vickie Arford, RN
• Phone: 720-833-5695
• Email: varford[@]bio2medical.com
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place.

Exclusion Criteria:

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Catheter Thrombosis
• Catheter-related Bloodstream Infection (CRBSI) Nos
• Deep Vein Thrombosis
• Embolism
• Medical Device Complication
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Bremerhaven Reinkenheide Hospital	Bremersheide
Germany	University of Mannheim	Mannheim
Italy	Ospendale Santa Maria di Loreto	Napoli
United Kingdom	Royal London Hospital	London
United Kingdom	Royal Berkshire Hospital	Reading

Sponsors (1)

Lead Sponsor	Collaborator
BiO2 Medical

Countries where clinical trial is conducted

Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of averted PE		At the time of the pre-removal cavogram	No
Secondary	Incidence and seriousness of all device-related adverse events		While the Angel Catheter is in place, including the insertion and removal procedures (Up to 30 days)	Yes
Secondary	Incidence and seriousness of deep vein thrombosis		From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days)	Yes
Secondary	Incidence and seriousness of catheter-related thrombosis		From device placement through removal (Up to 30 days)	Yes
Secondary	Incidence and seriousness of clinically significant PE		From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days)	Yes