Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

Completed · Not applicable

Conditions studied: Pulmonary Embolism

In brief

To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)

Key facts

Study ID

NCT03218566

Run by

Penumbra Inc.

People needed

119

Starts

2017-11-22

Expected to finish

2019-04-05

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• St. Joseph Health Hospital — Orange, California, United States
• Christiana Care — Newark, Delaware, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Grady Health System — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Our Lady of the Lake Hospital Inc. — Baton Rouge, Louisiana, United States
• Detroit Medical Center — Detroit, Michigan, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mercy Hospital South — St Louis, Missouri, United States
• New York University (NYU) Langone Medical Center — New York, New York, United States
• Mount Sinai — New York, New York, United States
• North Carolina Heart and Vascular Research (NCHVR) — Raleigh, North Carolina, United States
• University of Pennsylvania Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• Sanford Health — Sioux Falls, South Dakota, United States
• Sentara Vascular Specialists — Norfolk, Virginia, United States
• Charleston Area Medical Center (CAMC) — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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