FlowTriever Device for Pulmonary Embolism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the FlowTriever device for treating a specific type of blood clot in the lungs called a low-risk submassive pulmonary embolism. The goal is to determine if this device safely and effectively clears these clots without surgery. Candidates may qualify if scans show this type of clot, certain heart strain indicators are present, and they remain stable without major life support. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.
What prior data suggests that the FlowTriever device is safe for treating pulmonary embolism?
Research has shown that the FlowTriever device is generally safe for treating pulmonary embolism, a blockage in the lung's blood vessels. In one study, major complications occurred in only 1.8% of patients. The risk of death was very low, with only 0.3% of patients dying within 48 hours and 0.8% within 30 days. Another study reported no deaths, lung injuries, or heart injuries related to the device over six months.
In a separate study, only 4.6% of patients experienced serious issues, such as coughing up blood or needing a blood transfusion. These studies suggest that the FlowTriever device is well-tolerated and carries a low risk of serious side effects when used for this purpose.12345Why are researchers excited about this trial?
The FlowTriever device is unique because it provides a mechanical option for treating pulmonary embolism, a serious condition where blood clots block the arteries in the lungs. Unlike traditional treatments like anticoagulants and thrombolytics, which rely on drugs to dissolve clots, the FlowTriever physically removes clots from the body. Researchers are excited about this device because it has the potential to quickly and effectively clear blockages without the bleeding risks associated with clot-busting medications. This could lead to faster recovery times and fewer complications for patients.
What evidence suggests that the FlowTriever device is effective for pulmonary embolism?
Research has shown that the FlowTriever device, which participants in this trial will receive, effectively treats pulmonary embolism, a blockage in the lung's arteries. One study found the device worked as intended in 86% of cases. For high-risk patients, no deaths occurred within 30 days of using FlowTriever, highlighting its safety. Another study reported that patients experienced significant symptom improvements after treatment. While some risks, such as bleeding, exist, the device is generally considered safe. Overall, FlowTriever shows promise for effectively treating pulmonary embolism.678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mechanical thrombectomy using the FlowTriever device under conscious sedation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FlowTriever
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Inari Medical
Industry Sponsor
Citations
Single-Session INARI FlowTriever and Impella RP - PMC - NIH
The recently published multicenter single-arm FLARE IDE study (FlowTriever Pulmonary demonstrated the safety and effectiveness of the ...
Abstract No. 501
Technical success was achieved in 86% of cases. The overall complication rate was 15%, varying between massive (13/48, 27%) and submassive (2/53, 4%) groups.
3.
experts.umn.edu
experts.umn.edu/en/publications/mechanical-thrombectomy-for-high-risk-pulmonary-embolism-insights/Mechanical Thrombectomy for High-Risk Pulmonary Embolism
Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed ...
4.
dicardiology.com
dicardiology.com/content/real-pe-study-demonstrates-statistically-significant-lower-major-bleeding-rates-ekosREAL-PE Study Demonstrates Statistically Significant Lower ...
A rate of 12.4% for patients treated with the EKOS system vs. 17.3% for those treated with the FlowTriever system (p=0.0018),
FlowTriever2 Pulmonary Embolectomy Clinical Study
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical ...
6.
eurointervention.pcronline.com
eurointervention.pcronline.com/article/acute-outcomes-for-the-full-us-cohort-of-the-flash-mechanical-thrombectomy-registry-in-pulmonary-embolismAcute outcomes for the full US cohort of the FLASH ...
Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related ...
FlowTriever® system for the treatment of pulmonary ...
The FLASH data shows thrombus removal results in immediate improvements in cardiac function, acute symptom relief, and sustained long-term outcomes at 6 months.
Safety of the Inari FlowTriever device for mechanical ...
Another recent single-center retrospective study of 46 patients found the FlowTriever System safe and effective for acute massive/submassive PE, ...
Outcomes in High-Risk Pulmonary Embolism Patients ...
In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. Conclusions:.
10.
scai.org
scai.org/long-term-outcomes-following-large-bore-thrombectomy-flowtriever-system-treatment-pulmonaryLong-Term Outcomes Following Large-Bore ...
All –cause mortality was 0.3% at 48 hours post-thrombectomy, 0.8% at 30 days and 3.6% at 6 months. There were no deaths, pulmonary injuries or cardiac injuries ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.