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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03218566
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: Indigo Aspiration System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo Aspiration System in Acute Pulmonary Embolism
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. RV/LV ratio [ Time Frame: from baseline to 48 hours ]
    reduction in RV/LV ratio

  2. Major adverse events [ Time Frame: within 48 hours ]
    device related, major bleeding, device related SAEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Major trauma <14 days
  • Cardiovascular or pulmonary surgery within last 7 days
  • Cancer which requires 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218566


Contacts
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Contact: Erin Archard 510-995-9801 earchard@PENUMBRAINC.COM
Contact: Michaella Corso 510-995-2079 mcorso@penumbrainc.com

Locations
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United States, Florida
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Brian Schiro, MD         
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Akhilesh Sista, MD NYU-Langone School of Medicine

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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT03218566     History of Changes
Other Study ID Numbers: 11373
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Penumbra Inc.:
pulmonary embolism
clot

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases