Angel® Catheter Early Feasibility Clinical Study

NCT01847196 | Terminated Results DMC

• 1 other identifier: QD-155
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.

Conditions

Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism

Keywords

Pulmonary Embolism; PE; DVT; Deep Vein Thrombosis; VTE; Venous Thromboembolism; prophylaxis; thromboprophylaxis; contraindications to thromboprophylaxis; prophylactic; prevention; Inferior vena cava filter; IVC filter; filter; prevention of pulmonary embolism; trauma; critically-ill

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events Occuring for All Evaluable Subjects

  All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.

  From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days

Secondary Outcomes (1)

• Device Performance

  From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days

Study Arms (1)

Angel® Catheter

EXPERIMENTAL

All eligible subjects will receive an Angel® Catheter.

Device: Angel® Catheter

Interventions

Angel® Catheter DEVICE

The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed 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 device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.

Also known as: Angel Catheter, 2011-0420

Angel® Catheter

Eligibility Criteria

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

You may qualify if:

• Subject or legally authorized representative is willing and able to provide written informed consent, AND
• Subject is 18 years or older, AND
• Subject is currently admitted OR to be admitted to the Intensive Care Unit (ICU) within ≤36 hours of screening, AND
• Subject has a clinical need for a Central Venous Catheter, and/or the subject has an existing Central Venous Catheter that has been in place for \<36 hours before Angel® Catheter placement, AND
• Subject is considered at high risk for PE and meets ONE of the following criteria:
• Subject has multiple trauma with at least ONE of the following:
• Severe head injury
• Head injury with a long bone fracture
• Spinal cord injury with paraplegia or quadriplegia
• Multiple (≥2) long bone fractures
• Multiple (≥2) long bone fractures with pelvic fracture
• Pelvic fracture requiring open fixation
• Critically ill subject in the Intensive Care Unit with at least ONE of the following:
• Hemorrhagic or ischemic stroke
• Multiple organ failure

You may not qualify if:

• Subject is pregnant or lactating
• BMI = (Weight (lb) x 703)/(〖Height〗\^2 (inches)) \> 45; BMI may also be calculated at http://nhlbisupport.com/bmi/bminojs.htm
• Subject has a pre-existing IVC filter in place
• Subject is currently receiving prophylactic anticoagulation, other than aspirin or Plavix. Specifically, the subject is receiving any of the following medications: heparin, low molecular weight heparin, factor Xa inhibitors (i.e. xabans), Coumadin, and thrombin inhibitors.
• Subject has a diagnosis of pulmonary embolism
• Subject is participating in another clinical investigation
• Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
• Subject has functioning pelvic renal allograft on the only side available for device insertion
• Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
• Anatomic inability to place the Angel® Catheter (including a history of thrombosis of venous system on side of proposed access)
• Anticipated survival ≤48 hours

Sponsors & Collaborators

• BiO2 Medical: lead

Study Sites (4)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9158, United States

Location

University of Texas Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism; Wounds and Injuries; Critical Illness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Thromboembolism; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the small number of patients, analysis is descriptive only.

Results Point of Contact

• Title: Margaret Tumas, VP of Clinical Affairs
• Organization: BiO2 Medical

mtumas@bio2medical.com

720-635-3232

Study Officials

• Martin Schreiber, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Larry Martin, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• John Holcomb, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Michael Cripps, MD

  University of Texas Southwestern Medical Center (Dallas)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 26, 2015
• Results First Posted: August 14, 2015

Record last verified: 2015-08

Locations

US (4)