PEERLESS study
- Conditions
- 10014523Pulmonary embolism10003184
- Registration Number
- NL-OMON51587
- Lead Sponsor
- Inari Medical Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 12
Subjects must meet each of the following criteria to be included in the study:
1. Age * 18 years
2. Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary
angiographic evidence of any proximal filling defect in at least one main or
lobar pulmonary artery
3. Classification of intermediate-high-risk PE by ESC Guidelines 20191,
including ALL of the following:
a. Clinical signs and symptoms consistent with acute PE, or PESI class III-V,
or sPESI *1
AND
b. Hemodynamically stable
AND
c. RV dysfunction on echocardiography or CT
AND
d. Elevated cardiac troponin levels
4. Intervention planned to begin within 72 hours of the later of either
a. Confirmed PE diagnosis
OR
b. If transferring from another hospital, arrival at the treating hospital
5. Symptom onset within 14 days of confirmed PE diagnosis
Subjects will be excluded from the study for any of the following criteria:
1. Unable to anticoagulate with heparin, enoxaparin or other parenteral
antithrombin
2. Index presentation with hemodynamic instability that are part of the high-
risk PE definition in the ESC Guidelines 20191, including ANY of the following:
a. Cardiac arrest OR
b. Systolic BP < 90 mmHg or vasopressors required to achieve a BP *90 mmHg
despite adequate filling status, AND end-organ hypoperfusion
OR
c. Systolic BP < 90 mmHg or systolic BP drop *40 mmHg, lasting longer than 15
min and not caused by new-onset arrhythmia, hypovolemia, or sepsis
3. Known sensitivity to radiographic contrast agents that, in the
Investigator*s opinion, cannot be adequately pre-treated
4. Imaging evidence or other evidence that suggests, in the opinion of the
Investigator, the patient is not appropriate for catheter-based intervention
(e.g. inability to navigate to target location, clot limited to
segmental/subsegmental distribution, predominately chronic clot)
5. Patient has right heart clot in transit identified at baseline screening
6. Life expectancy < 30 days (e.g stage 4 cancer or severe COVID-19 infection),
as determined by the Investigator
7. Current participation in another drug or device study that, in the
Investigator*s opinion, would interfere with participation in this study
8. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH)
or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines1
9. Invasive systolic PA pressure *70 mmHg prior to study device entering the
body
10. Administration of bolus or drip/infusion thrombolytic therapy or mechanical
thrombectomy for the index PE event within 48 hours prior to enrollment
11. Ventriculararrhythmiasrefractorytotreatmentatthetimeofenrollment
12. Knowntohaveheparin-inducedthrombocytopenia(HIT)
13. Subject has any condition for which, in the opinion of the Investigator,
participation would not be in the best interest of the subject (e.g.,
compromise the well-being or that could prevent, limit, or confound the
protocol-specified assessments)
14. Subject has previously completed or withdrawn from this study
15. Patient unwilling or unable to conduct the follow up visits per protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a composite clinical endpoint constructed as a win<br /><br>ratio, a hierarchy of the following, assessed at hospital discharge or at 7<br /><br>days after the index procedure, whichever is sooner:<br /><br><br /><br>1. All-cause mortality, or<br /><br>2. Intracranial hemorrhage (ICH), or<br /><br>3. Major bleeding per ISTH definition4, or<br /><br>4. Clinical deterioration defined by hemodynamic or respiratory worsening,<br /><br>and/or escalation to a bailout therapy, or<br /><br>5. ICU admission and ICU length-of-stay during the index hospitalization and<br /><br>following the index procedure.</p><br>
- Secondary Outcome Measures
Name Time Method