NCT02186223 - The Angel® Catheter Pivotal Clinical Trial | Crick

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Enrollment

172

Conditions

Pulmonary Embolism Deep Vein Thrombosis Venous Thromboembolism Trauma

Interventions

The Angel® CatheterDEVICE

The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (21)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Freedom From Clinically Significant PE or Fatal PE During Treatment Period

1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.

Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)

Secondary Outcomes

Incidence of Acute Proximal Deep Vein Thrombosis

Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)

Incidence of Catheter Related Thrombosis

Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)

Incidence of Catheter Related Blood Stream Infections

Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)

Incidence of Major Bleeding Event

Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)

Incidence of PEs Averted