Angel® Catheter Post Market Registry

NCT02917135 | Unknown

• 1 other identifier: QD-180
• Study Type: observational
• Target: 2,000
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of averted PE

  At the time of the pre-removal cavogram

Secondary Outcomes (4)

• 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)

Study Arms (1)

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

Interventions

Angel® Catheter DEVICE

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.

Angel® Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• BiO2 Medical: lead

Study Sites (5)

Bremerhaven Reinkenheide Hospital

Bremersheide, Germany

RECRUITING

University of Mannheim

Mannheim, Germany

RECRUITING

Ospendale Santa Maria di Loreto

Napoli, Italy

RECRUITING

Royal London Hospital

London, United Kingdom

RECRUITING

Royal Berkshire Hospital

Reading, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Pyloric Stenosis, Hypertrophic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nicholas Bunker, MD

  Royal London Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vickie Arford, RN

CONTACT

720-833-5695; varford@bio2medical.com

Luis Angel, MD

CONTACT

langel@bio2medical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Target Duration: 33 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 28, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); DE (2); IT (1)