The Angel® Catheter Pivotal Clinical Trial

Completed · Not applicable

Conditions studied: Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism, Trauma

In brief

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).

Key facts

Study ID

NCT02186223

Run by

BiO2 Medical

People needed

172

Starts

2015-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• AND at least one of the following inclusion criteria (4,5, and/or 6)
• 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)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC San Diego Medical Center — San Diego, California, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• UF Health Shands Cancer Hospital — Gainesville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• Cooper University Hospital — Camden, New Jersey, United States
• University of New Mexico Health — Albuquerque, New Mexico, United States
• Mount Sinai Hospital — New York, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Regional One Health — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• John Peter Smith Health Network — Fort Worth, Texas, United States
• Ben Taub Hospital — Houston, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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