Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism

NCT01403090 | Completed Phase 1 Results DMC

• 1 other identifier: CPR-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .

Conditions

Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism

Keywords

Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism; Central Line Catheter; Vena Cava Filters

Outcome Measures

Primary Outcomes (1)

• Safety

  Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.

  30 days

Study Arms (1)

Angel Catheter

EXPERIMENTAL

Device: Angel Catheter

Interventions

Angel Catheter DEVICE

The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.

Angel Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years and older
• Be admitted to the hospital
• One of the following two criteria:
• Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria:
• Contraindications for anticoagulation
• Recurrent PE despite adequate anticoagulation
• Emergency treatment following massive pulmonary embolism
• Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including:
• Patients with multiple trauma and active or recent bleeding with contraindications to anticoagulation or that require a temporary stop of anticoagulation
• severe head injury with coma
• severe hemorrhagic stroke with coma
• head injury with a long bone fracture
• spinal cord injury with paraplegia or quadriplegia
• multiple (≥2) long bone fractures with pelvic fracture
• multiple (≥4) long bone fractures

You may not qualify if:

• Patient is less than 18 years
• Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit
• Patient or next legal representative cannot give informed consent
• Patients with anticipated survival \< 2 days (catastrophic illness)
• Body mass index greater than 35
• Patient has a pre-existing filter
• Participation in another simultaneous interventional medical investigation or interventional trial.
• Patient has indications for a permanent filter at the time of the initial evaluation
• Patient has an uncontrollable coagulopathy with active bleeding.
• Patient with proven endocarditis or bacteremia
• Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol
• Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins
• Patient with functioning pelvic renal allograft on the only side available for device insertion
• Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted

Sponsors & Collaborators

• BiO2 Medical: lead

Study Sites (2)

Clinica las Americas

Medellín, Antioquia, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Thromboembolism

Results Point of Contact

• Title: Luis Angel, MD
• Organization: BiO2 medical

langel@bio2medical.com

2102139778

Study Officials

• Carlos Cadavid, MD

  Hospital Pablo Tobon Uribe

  PRINCIPAL INVESTIGATOR

• Bladimir Gil, MD

  Clinica Las Americas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 20, 2013
• Results First Posted: May 20, 2013

Record last verified: 2013-04

Locations

CO (2)