Not a traditional drug phase: FlowTriever System for Pulmonary Embolism
Randomly assigned Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs.
Official registry: https://clinicaltrials.gov/study/NCT06588634 · Inari Medical · enrollment listed as 200
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are FlowTriever System, or Standard of Care. The registry lists allocation as randomized. Randomly assigned Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs.
They plan to enroll about 200 people at 34 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.
Official title (unrewritten)
The PERSEVERE Study
Interventions: FlowTriever System, Standard of Care
Primary outcome (registry wording): Composite clinical endpoint of the following adjudicated events:
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Tine Devolder
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
34 listed- Yale University — New Haven, Connecticut (recruiting)
- AdventHealth Orlando — Orlando, Florida (recruiting)
- Orlando Health Regional Medical Center — Orlando, Florida (recruiting)
- Sarasota Memorial Hospital — Sarasota, Florida (recruiting)
- Emory University — Atlanta, Georgia (recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi (recruiting)
- Robert Wood Johnson Medical School — New Brunswick, New Jersey (recruiting)
- Northwell Health — Bay Shore, New York (recruiting)
- SUNY, The University at Buffalo — Buffalo, New York (recruiting)
- Summa Akron — Akron, Ohio (recruiting)
- UPHS Penn Health System — Philadelphia, Pennsylvania (recruiting)
- UPMC — Pittsburgh, Pennsylvania (recruiting)
+ 18 sites outside the US on the same record
FAQ about this NCT record
Is NCT06588634 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06588634?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06588634?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary