Clinical trial NCT03218566: Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Official title: A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
clot
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Right Ventricle/Left Ventricle (RV:LV) Ratio
timeFrame: from baseline to 48 hours
measure: Major Adverse Event Rate
timeFrame: within 48 hours
Secondary outcomes:
measure: Device-related Death Rate
timeFrame: within 48 hours
measure: Major Bleeding Rate
timeFrame: within 48 hours
measure: Clinical Deterioration Rate
timeFrame: within 48 hours
measure: Pulmonary Vascular Injury Rate
timeFrame: within 48 hours
measure: Cardiac Injury Rate
timeFrame: within 48 hours
measure: Any-cause Mortality
timeFrame: within 30 days
measure: Device-related SAE Rate
timeFrame: within 30 days
measure: Symptomatic PE Recurrence Rate
timeFrame: within 30 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Orange
country: United States
facility: St. Joseph Health Hospital
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital Inc.
state: Louisiana
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: New York
country: United States
facility: New York University (NYU) Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular Research (NCHVR)
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pennsylvania Medical Center (UPMC)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center (CAMC)
state: West Virginia
Study officials:
affiliation: NYU-Langone School of Medicine
name: Akhilesh Sista, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.