N/A Completed N=172 Prevention

The Angel® Catheter Pivotal Clinical Trial

Chronic Obstructive Pulmonary Disease · Deep Vein Thrombosis · Venous Thromboembolism · Trauma

Source: ClinicalTrials.gov NCT02186223 ↗

Enrolled (actual)

172

Serious AEs

30.1%

Results posted

Apr 2017

Primary outcomePrimary: Freedom From Clinically Significant PE or Fatal PE During Treatment Period — 163 Participants

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).

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	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.