The Angel® Catheter Clinical Trial

Pulmonary Embolism Clinical Trial

Official title:

The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186223
• Other study ID #: QD-230
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: January 7, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: BiO2 Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Trauma
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Device:
• The Angel® Catheter
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.

Locations

Country	Name	City	State
United States	University of New Mexico Health	Albuquerque	New Mexico
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Cooper University Hospital	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Delray Medical Center	Delray Beach	Florida
United States	John Peter Smith Health Network	Fort Worth	Texas
United States	Broward Health Medical Center	Ft. Lauderdale	Florida
United States	UF Health Shands Cancer Hospital	Gainesville	Florida
United States	Ben Taub Hospital	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Regional One Health	Memphis	Tennessee
United States	Jackson Memorial Hospital	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	University of Texas Health Science Center	San Antonio	Texas
United States	UC San Diego Medical Center	San Diego	California
United States	Mercy Hospital St. Louis	St. Louis	Missouri
United States	St. Mary's Medical Center	West Palm Beach	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
BiO2 Medical	CardioMed Device Consultants, LLC, Intrinsic Imaging, LLC, Novella Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from clinically significant PE or fatal PE during treatment period	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.; 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.	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)	No
Secondary	Incidence of acute proximal deep vein thrombosis		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)	Yes
Secondary	Incidence of catheter related thrombosis		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)	Yes
Secondary	Incidence of catheter related blood stream infections		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)	Yes
Secondary	Incidence of major bleeding event		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)	Yes
Secondary	Incidence of PEs averted	During the pre-removal cavogram, the presence of signficant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.	During the pre-removal cavogram	No