FlowTriever System for Pulmonary Embolism

Recruiting at 10 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

Trial Summary

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 data supports the effectiveness of the FlowTriever treatment for pulmonary embolism?

The FlowTriever treatment for pulmonary embolism has shown a 90% success rate in reducing pulmonary artery pressures and improving heart function in patients with massive and submassive pulmonary embolism, according to studies. It is effective in treating intermediate-risk and high-risk pulmonary embolism without the need for clot-dissolving drugs, which can have bleeding risks. ^{1 2 3 4 5}

Is the FlowTriever System safe for treating pulmonary embolism?

The FlowTriever System has been shown to be safe for treating pulmonary embolism, as it allows for the removal of blood clots without the use of clot-dissolving drugs, which can have bleeding risks. Clinical studies and real-world experiences have demonstrated its safety in treating both intermediate-risk and high-risk pulmonary embolism. ^{1 3 4 6 7}

How is the FlowTriever treatment different from other treatments for pulmonary embolism?

The FlowTriever System is unique because it mechanically removes blood clots from the lungs without using thrombolytic drugs, which can have a high risk of causing bleeding. This makes it a safer option for some patients compared to traditional treatments that rely on medication to dissolve clots. ^{1 2 5 6 8}

What is the purpose of this trial?

RCT of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Research Team

Stavros Konstantinides, MD PhD

Principal Investigator

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

John M Moriarty, MD

Principal Investigator

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

Nicolas Meneveau, MD PhD

Principal Investigator

Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France

Jay Giri, MD, MPH

Principal Investigator

Penn Medicine, Philadelphia, PA, USA

Eligibility Criteria

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

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

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

My condition is classified as high-risk pulmonary embolism.

Exclusion Criteria

I have a history of chronic blood clots in my lungs.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

FlowTriever System for Pulmonary Embolism: A Review of Clinical Evidence. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Clot Extraction With the FlowTriever Device in Acute Massive Pulmonary Embolism. [2019]

5. Qatar pubmed.ncbi.nlm.nih.gov

Inari large-bore mechanical thrombectomy in intermediate-high risk submassive PE patients: Case series and literature review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A report of 2 cases of the use of the Inari FlowTriever System in the treatment of pulmonary embolism. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Catheter-Based Pulmonary Artery Embolectomy in Patients With Sub-Massive to Massive Pulmonary Embolism. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Thrombectomy in Emergency Department Patients with Pulmonary Embolism: The FLARE ED Sub-study. [2021]