FlowTriever Device for Pulmonary Embolism

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a device called FlowTriever to treat patients with certain types of blood clots in their lungs. These patients have clots that are not immediately life-threatening but still need treatment. The device works by physically removing the clots through a small, minimally invasive procedure. The FlowTriever System is the first FDA-approved mechanical thrombectomy device for treating pulmonary embolism, enabling nonsurgical removal of clots without thrombolytic medication.

Eligibility Criteria

This trial is for adults with low-risk submassive pulmonary embolism, which means they have certain heart strain or dilation and elevated heart-related proteins in their blood. They must be stable and not severely ill with COVID-19, pregnant, breastfeeding, unable to consent or take blood thinners.

Inclusion Criteria

I have a low-risk type of lung blood clot according to specific health guidelines.

I am 18 years old or older.

Exclusion Criteria

I am unable to give consent by myself.

Only subsegmental pulmonary embolism cases will be excluded.

Current participation in another study that may interfere with the patient's participation in this study

+5 more

Participant Groups

The study tests the FlowTriever device's effectiveness and safety in treating low-risk submassive pulmonary embolism by removing clots from lung arteries without surgery.

1Treatment groups

Experimental Treatment

Group I: FlowTrieverExperimental Treatment1 Intervention