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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with acute pulmonary embolism
  • Device: Indigo Aspiration System
    Indigo Aspiration System

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Penumbra Inc.

Study Contact

Joanne Krasnoff
650-455-4462
jkrasnoff@penumbrainc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.