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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218566
Recruitment Status : Completed
First Posted : July 14, 2017
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
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)
Actual Enrollment : 119 participants
Allocation: N/A
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
Actual Primary Completion Date : March 10, 2019
Actual Study Completion Date : April 5, 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. Right Ventricle/Left Ventricle (RV:LV) Ratio [ Time Frame: from baseline to 48 hours ]
    Change in RV/LV ratio per CTA

  2. 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)


Secondary Outcome Measures :
  1. Device-related Death Rate [ Time Frame: within 48 hours ]
  2. Major Bleeding Rate [ Time Frame: within 48 hours ]
  3. Clinical Deterioration Rate [ Time Frame: within 48 hours ]
  4. Pulmonary Vascular Injury Rate [ Time Frame: within 48 hours ]
  5. Cardiac Injury Rate [ Time Frame: within 48 hours ]
  6. Any-cause Mortality [ Time Frame: within 30 days ]
  7. Device-related SAE Rate [ Time Frame: within 30 days ]
  8. Symptomatic PE Recurrence Rate [ Time Frame: within 30 days ]


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)
  • 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

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


Locations
Show Show 22 study locations
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Akhilesh Sista, MD NYU-Langone School of Medicine
  Study Documents (Full-Text)

Documents provided by Penumbra Inc.:
Study Protocol  [PDF] June 12, 2018
Statistical Analysis Plan  [PDF] May 7, 2019

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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT03218566    
Other Study ID Numbers: 11373
First Posted: July 14, 2017    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Penumbra Inc.:
pulmonary embolism
clot
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases