N/A
N=172
The Angel® Catheter Pivotal Clinical Trial
Pulmonary Embolism · Deep Vein Thrombosis · Venous Thromboembolism · Trauma
Bottom Line
View on ClinicalTrials.gov: NCT02186223 ↗Enrolled (actual)
172
Serious AEs
30.1%
Results posted
Apr 2017
Primary outcome: Primary: Freedom From Clinically Significant PE or Fatal PE During Treatment Period — 163 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Angel® Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BiO2 Medical
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Clinically Significant PE or Fatal PE During Treatment Period |
163 | — |
| SECONDARY Incidence of Acute Proximal Deep Vein Thrombosis |
30 | — |
| SECONDARY Incidence of Catheter Related Thrombosis |
20 | — |
| SECONDARY Incidence of Catheter Related Blood Stream Infections |
— | — |
| SECONDARY Incidence of Major Bleeding Event |
5 | — |
| SECONDARY Incidence of PEs Averted |
14 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02186223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.