The Angel® Catheter Pivotal Clinical Trial

Bio2 Medical

Status: Completed

Conditions: Venous Thromboembolism; Pulmonary Embolism; Trauma; Deep Vein Thrombosis

Treatments: Device: The Angel® Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02186223

QD-230

Details and patient eligibility

About

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).

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject or legally authorized representative is willing and able to provide written informed consent,

2. Subject is 18 years or older,

3. 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)

4. 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

5. Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation

6. Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure

Exclusion criteria

1. Subject is pregnant
2. Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
3. Subject has a pre-existing IVC filter in place
4. BMI = > 45
5. Subject has functioning pelvic renal allograft on the only side available for device insertion
6. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
7. Anatomic inability to place the Angel® Catheter
8. Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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172 participants in 1 patient group

The Angel® Catheter

Experimental group

Description:

All eligible subjects will receive an Angel® Catheter.

Treatment:

Device: The Angel® Catheter