Angel® Catheter Post Market Registry

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.

Study Overview

• Status: Unknown
• Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Catheter-related Bloodstream Infection (CRBSI) Nos; Medical Device Complication; Catheter Thrombosis
• Intervention / Treatment: Device: Angel® Catheter

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Vickie Arford, RN; Phone Number: 720-833-5695; Email: varford@bio2medical.com
• Study Contact Backup: Name: Luis Angel, MD; Email: langel@bio2medical.com

Study Locations

• Germany
  • Bremersheide, Germany
    • Recruiting
    • Bremerhaven Reinkenheide Hospital
    • Contact: Ruediger Dissmann, MD
    • Contact: Olaf Kuek, MD; Email: olaf.kuek@klinikum-bremerhaven.de
  • Mannheim, Germany
    • Recruiting
    • University of Mannheim
    • Contact: Ibrahim Akin, MD; Email: ibrahim.akin@umm.de
    • Principal Investigator: Ibrahim Akin, MD
• Italy
  • Napoli, Italy
    • Recruiting
    • Ospendale Santa Maria di Loreto
    • Contact: Maurizio Postiglione, MD; Email: mandizio@alice.it
    • Principal Investigator: Maurizio Postiglione, MD
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal London Hospital
    • Contact: Nicholas Bunker, MD; Email: nicholas.bunker@bartshealth.nhs.uk
    • Principal Investigator: Nicholas Bunker, MD
  • Reading, United Kingdom
    • Recruiting
    • Royal Berkshire Hospital
    • Contact: Abby Brown; Email: abby.brown@royalberkshire.nhs.uk
    • Principal Investigator: Carl Waldmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of averted PE	At the time of the pre-removal cavogram

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
Incidence and seriousness of catheter-related thrombosis	From device placement through removal (Up to 30 days)
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)

Collaborators and Investigators

• Sponsor: BiO2 Medical
• Investigators: Principal Investigator: Nicholas Bunker, MD, Royal London Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Respiratory Tract Diseases; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Embolism and Thrombosis; Sepsis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: QD-180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No