Status:
COMPLETED
The Angel® Catheter Pivotal Clinical Trial
Lead Sponsor:
BiO2 Medical
Collaborating Sponsors:
CardioMed Device Consultants, LLC
Intrinsic Imaging, LLC
Conditions:
Pulmonary Embolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT02186223
Start Date
January 1 2015
End Date
December 1 2015
Last Update
April 4 2017
Active Locations (21)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
UC San Diego Medical Center
San Diego, California, United States, 92103
3
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
4
Delray Medical Center
Delray Beach, Florida, United States, 33483