The Angel® Catheter Pivotal Clinical Trial
The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
1 other identifier
interventional
172
1 country
21
Brief Summary
The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedApril 4, 2017
February 1, 2017
11 months
July 7, 2014
December 14, 2016
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
Secondary Outcomes (5)
Incidence of Acute Proximal Deep Vein Thrombosis
Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Catheter Related Thrombosis
Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Catheter Related Blood Stream Infections
Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of Major Bleeding Event
Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
Incidence of PEs Averted
During the pre-removal cavogram (An average of 6.8 days after device insertion)
Study Arms (1)
The Angel® Catheter
EXPERIMENTALAll eligible subjects will receive an Angel® Catheter.
Interventions
The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into 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 (less than 30 days) vascular access via the femoral vein.
Eligibility Criteria
You may qualify if:
- Subject or legally authorized representative is willing and able to provide written informed consent,
- Subject is 18 years or older,
- Subject is expected to remain in a critical care setting for at least 72 hours,
- Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:
- Active bleeding or at high risk for bleeding OR
- Hypersensitivity to pharmacological thromboprophylaxis OR
- History of severe heparin induced thrombocytopenia OR
- Severe thrombocytopenia
- Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
- Subject requires a temporary interruption (\>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
You may not qualify if:
- Subject is pregnant
- Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
- Subject has a pre-existing IVC filter in place
- BMI = \> 45
- 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
- Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BiO2 Medicallead
- CardioMed Device Consultants, LLCcollaborator
- Intrinsic Imaging, LLCcollaborator
- Novella Clinicalcollaborator
Study Sites (21)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UC San Diego Medical Center
San Diego, California, 92103, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Delray Medical Center
Delray Beach, Florida, 33483, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
UF Health Shands Cancer Hospital
Gainesville, Florida, 32608, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
University of New Mexico Health
Albuquerque, New Mexico, 87106, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Regional One Health
Memphis, Tennessee, 38103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
John Peter Smith Health Network
Fort Worth, Texas, 76104, United States
Ben Taub Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Bio2 Medical, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Tapson, MD
Cedars Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
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
July 7, 2014
First Posted
July 10, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 4, 2017
Results First Posted
April 4, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share