FlowTriever System for Pulmonary Embolism

Recruiting at 24 trial locations

Overseen By Tine Devolder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inari Medical

Must not be taking: Thrombolytics, Anticoagulants

Disqualifiers: Neurological deficit, Stroke, Bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 7 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with high-risk pulmonary embolism, a serious condition where a blood clot obstructs blood flow to the lungs. The study compares the FlowTriever System, a device that removes clots, with standard treatment methods to determine which approach benefits patients more. Candidates for the trial include those with severe pulmonary embolism and signs of heart strain, indicated by a specific heart ratio. As an unphased trial, it provides patients the chance to contribute to groundbreaking research that could enhance treatment options for this serious condition.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are unable to take blood thinners or have a condition called heparin-induced thrombocytopenia, you may not be eligible to participate.

What prior data suggests that the FlowTriever System is safe for treating pulmonary embolism?

Research has shown that the FlowTriever System is generally safe for treating serious cases of blood clots in the lungs, known as pulmonary embolism (PE). Studies have found that this device effectively removes clots, providing quick relief from symptoms and improving heart function. A large study in the U.S. reported that the FlowTriever System was safe to use. Most patients experienced little to no trouble breathing six months after the procedure. These results suggest that the FlowTriever System is well-tolerated, with few serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for pulmonary embolism, which often involve anticoagulation therapy or invasive surgery, the FlowTriever System is a mechanical thrombectomy device designed to physically remove blood clots from the lungs. Researchers are excited about the FlowTriever because it offers a minimally invasive option that can provide rapid symptom relief without the need for blood-thinning medications, which can have significant side effects. This device specifically targets and removes clots, potentially reducing the risk of bleeding complications and offering a quicker recovery time compared to conventional treatments.

What evidence suggests that the FlowTriever System is effective for pulmonary embolism?

Research has shown that the FlowTriever System can effectively treat high-risk pulmonary embolism, a condition where a blood clot blocks blood flow in the lungs. In this trial, participants will receive either the FlowTriever System or standard care treatment. Studies have found that the FlowTriever System, a tool for removing clots, offers better safety and reduces the risk of in-hospital death compared to standard treatments. Specifically, one study reported that 90.1% of patients experienced no or only mild breathing problems six months after treatment. Another study demonstrated improved blood flow and patient function shortly after use. These findings suggest that the FlowTriever System holds promise for effectively treating pulmonary embolism. ^{2 3 4 5 6}

Who Is on the Research Team?

Jay Giri, MD, MPH

Principal Investigator

Penn Medicine, Philadelphia, PA, USA

John M Moriarty, MD

Principal Investigator

Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA

Stavros Konstantinides, MD PhD

Principal Investigator

Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany

Nicolas Meneveau, MD PhD

Principal Investigator

Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France

Are You a Good Fit for This Trial?

The PERSEVERE study is for adults over 18 with a high-risk class of acute pulmonary embolism (PE), which means they have a blockage in the lung's main artery. They must also show right ventricle dysfunction due to this condition and be able to start treatment within 4 hours of diagnosis.

Inclusion Criteria

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

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

My condition is classified as high-risk pulmonary embolism.

Exclusion Criteria

End-stage medical condition with life expectancy <3 months (irrespective of the severity of acute PE), as determined by the Investigator

Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions

Subject has previously completed or withdrawn from this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the FlowTriever System or Standard of Care for high-risk pulmonary embolism

Up to 7 days

In-hospital treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FlowTriever System

Trial Overview This randomized controlled trial compares two treatments for severe PE: the standard care typically given for such cases versus an intervention using the FlowTriever System, which is designed to remove blood clots from the arteries in the lungs.

How Is the Trial Designed?

Group I: Standard of Care Active Control 1 Intervention

Group II: FlowTriever Active Control 1 Intervention

FlowTriever System is already approved in United States, European Union for the following indications:

Approved in United States as FlowTriever for:

• Pulmonary embolism
• Removal of emboli and thrombi from blood vessels

Approved in European Union as FlowTriever for:

• Pulmonary embolism
• Removal of emboli and thrombi from blood vessels

Who Is Running the Clinical Trial?

Inari Medical

Lead Sponsor

Trials

18

Recruited

5,300+

Published Research Related to This Trial

The FlowTriever System is a mechanical thrombectomy device that effectively treats pulmonary embolism (PE) without the bleeding risks associated with thrombolytic drugs, making it a safer option for patients at intermediate and high risk.

Clinical data from multiple studies, including the FlowTriever Pulmonary Embolectomy Clinical Study, demonstrate the device's safety and effectiveness in resolving vascular occlusions and improving patient outcomes in PE cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FlowTriever System for Pulmonary Embolism: A Review of Clinical Evidence. Haner Wasserstein, D., Frishman, WH.[2023]

In a study of 38 patients with pulmonary embolism treated with the FlowTriever device, there was a significant improvement in mean pulmonary artery pressure by 22% after thrombectomy, indicating its efficacy in managing submassive PE.

While the procedure was generally safe, with no device-related complications, 5.26% of patients experienced significant adverse events, highlighting the need for further randomized trials to assess the safety and efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Catheter-Based Pulmonary Artery Embolectomy in Patients With Sub-Massive to Massive Pulmonary Embolism. Elmoghrabi, A., Shafi, I., Abdelrahman, A., et al.[2023]

The FlowTriever device was successfully used in a case of acute massive pulmonary embolism (PE) where traditional treatments like anticoagulation and thrombolysis were either ineffective or not possible.

This case report represents the first documented use of the FlowTriever device, highlighting its potential as a novel treatment option for patients with limited therapeutic choices in acute PE situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clot Extraction With the FlowTriever Device in Acute Massive Pulmonary Embolism. Weinberg, AS., Dohad, S., Ramzy, D., et al.[2019]

In a study of 76 emergency department patients with acute intermediate-risk pulmonary embolism, mechanical embolectomy significantly reduced the right ventricular/left ventricular (RV/LV) ratio by an average of 0.37, indicating improved heart function after the procedure.

The procedure was associated with a low rate of major adverse events (MAEs), with only three patients experiencing complications, suggesting that mechanical embolectomy is a safe and effective treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Thrombectomy in Emergency Department Patients with Pulmonary Embolism: The FLARE ED Sub-study. Jaber, WA., Kabrhel, C., Rosenfield, K., et al.[2021]

Catheter-directed thrombectomy using the FlowTriever system has shown promising results in treating patients with acute intermediate-high risk pulmonary embolism (PE), leading to rapid improvements in pulmonary artery pressure.

In three reported cases of submassive PE, immediate hemodynamic improvements were observed after successful mechanical thrombectomy, suggesting that this method could be a beneficial treatment option, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inari large-bore mechanical thrombectomy in intermediate-high risk submassive PE patients: Case series and literature review. Mathbout, MF., Hennawi, HA., Khedr, A., et al.[2022]

The FlowTriever System is the first FDA-approved device for mechanically removing blood clots from the lungs, providing a nonsurgical option for treating pulmonary embolism.

In two reported cases, the FlowTriever successfully treated pulmonary embolism and right atrial thrombus without the risks associated with thrombolytic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A report of 2 cases of the use of the Inari FlowTriever System in the treatment of pulmonary embolism. Pham, R., Ushinsky, AS., Mani, N., et al.[2022]

The FlowTriever device achieved 100% technical success in treating 46 patients with acute central pulmonary embolism, significantly reducing mean pulmonary artery pressure after the procedure (from 33.9 mm Hg to 27.0 mm Hg).

All patients survived to hospital discharge, with a low complication rate of 4.6%, indicating that the FlowTriever is a safe and effective option for managing both massive and submassive pulmonary embolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. Wible, BC., Buckley, JR., Cho, KH., et al.[2020]

The FlowTriever thrombectomy system demonstrated a 90% success rate in treating massive and submassive pulmonary embolism in 34 patients, effectively reducing pulmonary artery pressures and improving cardiac performance within 24 hours.

This intervention led to significant improvements in cardiac index, blood pressure, and heart rates, while also decreasing the need for vasopressor support, highlighting its efficacy in managing severe pulmonary embolism cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The expanding role of percutaneous mechanical thrombus debulking and extraction in the treatment of critical pulmonary embolism. Topaz, O.[2021]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013406

Outcomes in High-Risk Pulmonary Embolism Patients ... The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE.

2. americanjir.com americanjir.com/safety-and-outcomes-with-use-of-flowtriever-for-mechanical-thrombectomy-i-n-acute-pulmonary-embolism/

Safety and outcomes with use of FlowTriever for ... We present the largest single-center data set studied to-date for safety, mortality, and outcomes post-mechanical thrombectomy including ...

3. scai.org scai.org/long-term-outcomes-following-large-bore-thrombectomy-flowtriever-system-treatment-pulmonary

Long-Term Outcomes Following Large-Bore ... 90.1% of patients reported “no or mild dyspnea” at 6 months post-procedure. Randomized controlled trials will be important to further investigate the long-term ...

4. eurointervention.pcronline.com eurointervention.pcronline.com/article/acute-outcomes-for-the-full-us-cohort-of-the-flash-mechanical-thrombectomy-registry-in-pulmonary-embolism

Acute outcomes for the full US cohort of the FLASH ... Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9521880/

Percutaneous Large-Bore Pulmonary Thrombectomy with the ... A propensity score analysis published in 2021 comparing MT with the FlowTriever and routine care found MT to decrease in-hospital mortality and ...

6. inarimedical.com inarimedical.com/flowtriever-system

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.