RecruitingNot Applicable

The PERSEVERE Study

United States200 participantsStarted 2024-12-16

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

✕. 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)
✕. Recent cranial or spinal surgery (\<14 days)
✕. Life-threatening active bleeding or hemorrhage into a critical area
✕. Known intracranial tumor
✕. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator

Composite clinical endpoint of the following adjudicated events:

Timeframe: The earlier of initial hospital discharge or 7 days after randomization

NCT IDNCT06588634

SponsorInari Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Tine Devolder

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

✕. 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)
✕. Recent cranial or spinal surgery (\<14 days)
✕. Life-threatening active bleeding or hemorrhage into a critical area
✕. Known intracranial tumor
✕. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator