Health Trials

The PERSEVERE Study

ConditionsPulmonary EmbolismPulmonary Thromboembolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInari Medical

About this trial

Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at enrollment ≥18 years

Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery

High-risk class of acute PE

RV dysfunction, as defined RV/LV ratio ≥1.0

Disqualifiers

Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.

Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention

Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH

Recent stroke (<14 days)

Trial design

Design model

Parallel

Treatments tested in this trial

  • FlowTriever System

    Device

    Mechanical thrombectomy for pulmonary embolism

  • Standard of Care

    Procedure/Surgery

    Standard of care treatment for pulmonary embolism

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: FlowTrieverActive comparator 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite clinical endpoint of the following adjudicated events:

1. All-cause mortality 2. Cardiac arrest 3. Bailout to an alternative therapeutic strategy 4. Major bleeding 5. ECMO life support

Time frame
The earlier of initial hospital discharge or 7 days after randomization

Secondary outcomes

1

All-cause mortality

Time frame
At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
2

Cardiac arrest

Time frame
At the earlier of initial hospital discharge or 7 days post randomization
3

Bailout to an alternative therapeutic strategy

Time frame
At the earlier of initial hospital discharge or 7 days post randomization
4

Major bleeding

Time frame
At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inari Medical

Lead sponsor

Source ClinicalTrials.gov
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