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Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

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: NCT04798261
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

Condition or disease Intervention/treatment
Pulmonary Embolism Device: Indigo Aspiration System

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
Actual Study Start Date : June 25, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with acute pulmonary embolism Device: Indigo Aspiration System
Indigo Aspiration System




Primary Outcome Measures :
  1. Safety: Composite of major adverse events [ Time Frame: 48 hours ]
    A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury

  2. Performance: Change in RV/LV Ratio [ Time Frame: 48 hours post-procedure ]
    Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)


Secondary Outcome Measures :
  1. Quality of Life assessed via PEmb-QoL [ Time Frame: 90 days post-procedure ]
    Self-assessment of PE related complaints and daily living limitations (including work and social)

  2. Quality of Life assessed via EQ-5D-5L [ Time Frame: 90 days post-procedure ]
    Self-assessment of activities of daily living

  3. Functional outcome assessed NYHA [ Time Frame: 90 days post-procedure ]
    Physician assessment of heart failure symptoms and activity level

  4. Functional outcome assessed via 6MWT [ Time Frame: 90 days post-procedure ]
    Walking distance over a 6 minute period to assess functional capacity

  5. Perceived dyspnea assessed via Borg Scale [ Time Frame: 90 days post-procedure ]
    Category rating scale to measure perceived dyspnea

  6. Incidence of device related SAE(s) [ Time Frame: 365 days ]
  7. Any-cause mortality [ Time Frame: Within 30 days ]
  8. Symptomatic PE recurrence [ 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
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute pulmonary embolism
Criteria

Inclusion Criteria:

  1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
  2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
  3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
  4. Patient is ≥ 18 years of age
  5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements

Exclusion Criteria:

  1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
  2. Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study
  3. Known serious, uncontrolled sensitivity to radiographic agents
  4. Life expectancy < 180 days
  5. Patients on ECMO
  6. Pregnant patients
  7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
  8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the 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): NCT04798261


Contacts
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Contact: Meghan Beatty 757-759-2898 mbeatty@penumbrainc.com
Contact: Erin Archard 802-377-9715 earchard@penumbrainc.com

Locations
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United States, Florida
Radiology and Imaging Specialists Recruiting
Lakeland, Florida, United States, 33805
United States, Michigan
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
United States, New York
Columbia University Medical Center/NYPH Not yet recruiting
New York, New York, United States, 10032
United States, Virginia
Sentara Norfolk General Recruiting
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Penumbra Inc.
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT04798261    
Other Study ID Numbers: 18135
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases