The Angel® Catheter Pivotal Clinical Trial

NCT ID: NCT02186223

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief 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).

Conditions

Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism; Trauma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The Angel® Catheter

All eligible subjects will receive an Angel® Catheter.

Group Type: EXPERIMENTAL

The Angel® Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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,

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioMed Device Consultants, LLC

INDUSTRY

Sponsor Role: collaborator

Intrinsic Imaging, LLC

UNKNOWN

Sponsor Role: collaborator

Novella Clinical

OTHER

Sponsor Role: collaborator

BiO2 Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor Tapson, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Sinai

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

UC San Diego Medical Center

San Diego, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Delray Medical Center

Delray Beach, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

UF Health Shands Cancer Hospital

Gainesville, Florida, United States

Jackson Memorial Hospital

Miami, Florida, United States

St. Mary's Medical Center

West Palm Beach, Florida, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

Cooper University Hospital

Camden, New Jersey, United States

University of New Mexico Health

Albuquerque, New Mexico, United States

Mount Sinai Hospital

New York, New York, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Regional One Health

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

John Peter Smith Health Network

Fort Worth, Texas, United States

Ben Taub Hospital

Houston, Texas, United States

University of Texas Health Science Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

QD-230

Identifier Type: -

Identifier Source: org_study_id