Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism (EXTRACT-PE)

July 30, 2020 updated by: Penumbra Inc.

A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center - Tucson
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Orange, California, United States, 92868
        • St. Joseph Health Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Tampa, Florida, United States, 33613
        • AdventHealth Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Hospital Inc.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University Of Minnesota Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Mercy Hospital South
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai
      • New York, New York, United States, 10016
        • New York University (NYU) Langone Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Heart and Vascular Research (NCHVR)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 16148
        • University of Pennsylvania Medical Center (UPMC)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Health
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Vascular Specialists
    • West Virginia
      • Charleston, West Virginia, United States, 25309
        • Charleston Area Medical Center (CAMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single Arm
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Device: Indigo Aspiration System
use of mechanical thrombectomy to treat pulmonary embolism

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Right Ventricle/Left Ventricle (RV:LV) Ratio
Time Frame: from baseline to 48 hours
Change in RV/LV ratio per CTA
from baseline to 48 hours
Major Adverse Event Rate
Time Frame: within 48 hours
A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
within 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Device-related Death Rate
Time Frame: within 48 hours
within 48 hours
Major Bleeding Rate
Time Frame: within 48 hours
within 48 hours
Clinical Deterioration Rate
Time Frame: within 48 hours
within 48 hours
Pulmonary Vascular Injury Rate
Time Frame: within 48 hours
within 48 hours
Cardiac Injury Rate
Time Frame: within 48 hours
within 48 hours
Any-cause Mortality
Time Frame: within 30 days
within 30 days
Device-related SAE Rate
Time Frame: within 30 days
within 30 days
Symptomatic PE Recurrence Rate
Time Frame: within 30 days
within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penumbra Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Akhilesh Sista, MD, NYU-Langone School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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