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

Not Applicable

Completed

• Conditions: Pulmonary Embolism

• 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

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-11-22
• Primary Completion: 2019-03-10
• Study Completion: 2019-04-05
• Results First Submitted: 2020-03-24
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Results First Posted: 2020-08-03
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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
Device-related Death Rate	within 48 hours
Major Bleeding Rate	within 48 hours
Clinical Deterioration Rate	within 48 hours

Trial Locations

Locations (22)

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

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