The Angel® Catheter Clinical Trial

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

David Woodrum, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20151024

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