Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Indigo Aspiration System
- Registration Number
- NCT03218566
- Lead Sponsor
- Penumbra Inc.
- Brief Summary
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
- Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio > 0.9
- Patient is 18 years of age or older
- tPA use within 14 days prior to baseline CTA
- Systolic BP < 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
- Pulmonary hypertension with peak PA > 70 mmHg by right heart catheterization
- History of severe or chronic pulmonary hypertension
- Fi02 requirement > 40% or >6 LPM to keep oxygen saturations >90%
- Hematocrit < 28%
- Platelets < 100,000µL
- Serum creatinine > 1.8 mg/dL
- INR > 3
- aPTT (or PTT) > 50 seconds on no anticoagulation
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic doses of anticoagulants
- Major trauma < 14 days
- Presence of intracardiac lead
- Cardiovascular or pulmonary surgery within last 7 days
- Cancer requiring active chemotherapy
- Known serious, uncontrolled sensitivity to radiographic agents
- Life expectancy < 90 days
- Female who is pregnant
- Intracardiac Thrombus
- Patients on ECMO
- Current participation in another investigational study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Indigo Aspiration System Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
- Primary Outcome Measures
Name Time Method Major Adverse Event Rate within 48 hours A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
Right Ventricle/Left Ventricle (RV:LV) Ratio from baseline to 48 hours Change in RV/LV ratio per CTA
- Secondary Outcome Measures
Name Time Method Pulmonary Vascular Injury Rate within 48 hours Cardiac Injury Rate within 48 hours Any-cause Mortality within 30 days Device-related SAE Rate within 30 days Symptomatic PE Recurrence Rate within 30 days Clinical Deterioration Rate within 48 hours Device-related Death Rate within 48 hours Major Bleeding Rate within 48 hours
Trial Locations
- Locations (22)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mount Sinai
🇺🇸New York, New York, United States
North Carolina Heart and Vascular Research (NCHVR)
🇺🇸Raleigh, North Carolina, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
St. Joseph Health Hospital
🇺🇸Orange, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Grady Health System
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
AdventHealth Tampa
🇺🇸Tampa, Florida, United States
Mercy Hospital South
🇺🇸Saint Louis, Missouri, United States
New York University (NYU) Langone Medical Center
🇺🇸New York, New York, United States
University of Pennsylvania Medical Center (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Christiana Care
🇺🇸Newark, Delaware, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Our Lady of the Lake Hospital Inc.
🇺🇸Baton Rouge, Louisiana, United States
Banner University Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Charleston Area Medical Center (CAMC)
🇺🇸Charleston, West Virginia, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States