Clinical trial NCT02186223: The Angel® Catheter Pivotal Clinical Trial
Official title: The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Trauma
Keywords: Pulmonary Embolism
PE
DVT
Deep Vein Thrombosis
VTE
Venous Thromboembolism
prophylaxis
thromboprophylaxis
contraindications to thromboprophylaxis
prophylactic
prevention
Inferior vena cava filter
IVC filter
filter
prevention of pulmonary embolism
trauma
critically-ill
Lead sponsor: BiO2 Medical
Sponsor class: INDUSTRY
Collaborators: name: CardioMed Device Consultants, LLC
name: Intrinsic Imaging, LLC
name: Novella Clinical
First posted: 2014-07-10
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


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,

   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)

Primary outcomes:
measure: Freedom From Clinically Significant PE or Fatal PE During Treatment Period
timeFrame: 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:
measure: Incidence of Acute Proximal Deep Vein Thrombosis
timeFrame: 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)
measure: Incidence of Catheter Related Thrombosis
timeFrame: 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)
measure: Incidence of Catheter Related Blood Stream Infections
timeFrame: 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)
measure: Incidence of Major Bleeding Event
timeFrame: 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)
measure: Incidence of PEs Averted
timeFrame: During the pre-removal cavogram (An average of 6.8 days after device insertion)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Ft. Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands Cancer Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: St. Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health
state: New Mexico
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: John Peter Smith Health Network
state: Texas
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Cedars Sinai
name: Victor Tapson, MD
role: PRINCIPAL_INVESTIGATOR
References: