FlowTriever System + Anticoagulation for Pulmonary Embolism

Recruiting at 88 trial locations

Overseen By Wissam Jaber, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inari Medical

Must be taking: Anticoagulants

Disqualifiers: Hemodynamic instability, CTEPH, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 48

Duration: 4 weeks

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to take certain blood thinners like heparin or enoxaparin to participate.

What data supports the effectiveness of the FlowTriever System + Anticoagulation treatment for Pulmonary Embolism?

Research shows that the FlowTriever System is effective in treating pulmonary embolism by safely removing blood clots without the need for clot-dissolving drugs, which can have bleeding risks. Studies and real-world experiences demonstrate its success in improving blood flow and reducing pressure in the lungs for patients with high-risk pulmonary embolism. ^{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 and effectiveness in treating different risk levels of pulmonary embolism. ^{1 2 3 5 6}

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

The FlowTriever System is unique because it mechanically removes blood clots from the lungs without the need for thrombolytic drugs, which can have bleeding risks. This makes it a safer option for patients who cannot use traditional clot-busting medications. ^{1 2 3 4 5}

Research Team

Bernhard Gebauer, MD

Principal Investigator

Charité University Hospital Berlin

Felix Mahfoud, MD

Principal Investigator

Universitaetsspital Basel

Jay Giri, MD

Principal Investigator

Penn Medicine

Frances Mae West, MD

Principal Investigator

Jefferson Health,

Eligibility Criteria

The PEERLESS II Study is for adults over 18 with a recent pulmonary embolism (PE) diagnosis, specific heart dysfunction due to PE, and additional risk factors like low blood pressure or elevated heart rate. People can't join if they've had certain advanced treatments for PE in the last month, have severe conditions limiting life expectancy, are pregnant, or have contraindications to the FlowTriever System or anticoagulants.

Inclusion Criteria

I have at least two risk factors from different categories related to heart, blood markers, or breathing.

You have a condition where the right side of your heart is not working properly, as shown by specific tests.

My symptoms started within 14 days after my PE was confirmed.

Exclusion Criteria

I received advanced treatment for a blood clot in my lung within the last 30 days.

I had a severe blood clot in my lung and was very unstable but am stable now.

I have or had chronic lung blood clot issues as per 2019 guidelines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the FlowTriever System plus anticoagulation or anticoagulation alone for intermediate-risk acute PE

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Visits at 48 hours, 1 month, and 3 months

Extension

Participants may continue to be monitored for long-term outcomes

Up to 6 months

Treatment Details

Interventions

• Anticoagulation Agents
• FlowTriever System

Trial Overview This trial tests the FlowTriever System plus standard blood thinners against blood thinners alone in treating intermediate-risk acute PE. Participants will be randomly assigned to one of these two approaches to compare effectiveness and safety.

Participant Groups

Group I: FlowTriever Active Control 1 Intervention

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Group II: Anticoagulation Active Control 1 Intervention

Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. Anticoagulants are a group of medications that decrease your blood's ability to clot.

Anticoagulation Agents is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Various Anticoagulants for:

• Atrial fibrillation
• Deep vein thrombosis (DVT)
• Pulmonary embolism
• Stroke prevention

Approved in United States as Various Anticoagulants for:

• Atrial fibrillation
• Deep vein thrombosis (DVT)
• Pulmonary embolism
• Stroke prevention
• Hip or knee replacement surgery

Approved in Canada as Various Anticoagulants for:

• Atrial fibrillation
• Deep vein thrombosis (DVT)
• Pulmonary embolism
• Stroke prevention

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 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 43,252 cancer-free patients with venous thromboembolism, apixaban was found to have a significantly lower major bleeding risk compared to warfarin and rivaroxaban during the initial treatment phase.

During extended treatment, apixaban and rivaroxaban had similar bleeding risks, both lower than that of warfarin, indicating that apixaban may be a safer long-term option for anticoagulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of type of oral anticoagulation with risk of bleeding in 45,114 patients with venous thromboembolism during initial and extended treatment-A nationwide register-based study. Glise Sandblad, K., Schulman, S., Rosengren, A., et al.[2023]

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

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

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

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

4. Qatar pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Association of type of oral anticoagulation with risk of bleeding in 45,114 patients with venous thromboembolism during initial and extended treatment-A nationwide register-based study. [2023]