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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat pulmonary embolism (PE), where blood clots block lung arteries. Researchers compare two treatments: the FlowTriever System, a device for clot removal, combined with anticoagulation agents, versus the medication alone. The goal is to determine if the FlowTriever System improves outcomes for individuals with intermediate-risk acute PE. Ideal participants are those recently diagnosed with PE, experiencing symptoms like shortness of breath, and showing signs of heart strain. As an unphased trial, this study allows participants to contribute to innovative research that could enhance PE treatment options.

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

Research has shown that the FlowTriever System, a tool for removing blood clots, is generally safe. Studies have found that it can improve heart function and relieve symptoms shortly after treatment. Long-term results, observed over six months, are also encouraging.

Conversely, blood-thinning medications like Heparin and Rivaroxaban are usually well-tolerated but carry some risks. The first few weeks of taking these medications may present a higher chance of side effects, especially during the transition from hospital to home care. However, they effectively reduce the risk of blood clots and have a lower chance of causing major bleeding compared to some other treatments.

Both treatments have undergone thorough study, and the safety information is reassuring for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FlowTriever System and anticoagulation agents for pulmonary embolism because they offer a unique approach compared to traditional treatments. Unlike standard anticoagulation medications, which work by thinning the blood to prevent clotting, the FlowTriever System directly removes blood clots through a mechanical thrombectomy. This can potentially provide faster relief of symptoms and reduce the risk of long-term complications. The combination of mechanical intervention with anticoagulation could enhance the overall effectiveness of treatment, offering a more comprehensive solution for managing pulmonary embolism.

What evidence suggests that the FlowTriever System plus anticoagulation could be effective for pulmonary embolism?

Research has shown that the FlowTriever System could help treat pulmonary embolism (PE). One study found that this device, which removes blood clots, improved heart function and blood flow and lowered the risk of death in patients with severe PE. Another study found that the FlowTriever System is safe and effective, leading to better results than standard treatments. In this trial, some participants will receive treatment with the FlowTriever System.

Meanwhile, medications like Heparin and Rivaroxaban are well-known for preventing blood clots and are commonly used to treat PE. They thin the blood to stop more clots from forming. Other participants in this trial will receive these anticoagulation medications. Using the FlowTriever System along with these medications might offer extra benefits by both removing existing clots and preventing new ones. ^{6 7 8 9 10}

Who Is on the Research Team?

Jay Giri, MD

Principal Investigator

Penn Medicine

Felix Mahfoud, MD

Principal Investigator

Universitaetsspital Basel

Bernhard Gebauer, MD

Principal Investigator

Charité University Hospital Berlin

Frances Mae West, MD

Principal Investigator

Jefferson Health,

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 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]

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 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 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]

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. 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 ...

4. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949912724000011

Mechanical thrombectomy devices for the management of ... Outcomes in high-risk pulmonary embolism patients undergoing FlowTriever mechanical thrombectomy or other contemporary therapies: results From the FLAME study.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK519025/

Anticoagulation Safety - StatPearls - NCBI Bookshelf - NIH The initial weeks of oral anticoagulant use pose the highest risk of adverse effects, particularly during transitions from hospital to home care ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828658

Evidence-Based Anticoagulation for Acute Pulmonary Embolism In a systematic review of 21 trials for treatment of venous thromboembolism, LMWHs were associated with a lower risk of major hemorrhage (odds ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.024425

Extended Anticoagulation After Pulmonary Embolism Primary efficacy outcome was all‐cause death or recurrent venous thromboembolism. Primary safety outcome was major bleeding. In total, 858 (71.5 ...

9. emedicine.medscape.com emedicine.medscape.com/article/300901-treatment

Pulmonary Embolism (PE) Treatment & Management The AMPLIFY study showed that, in comparison with the standard anticoagulant regimen apixaban therapy resulted in a 16% reduction in the risk of ...

10. ashpublications.org ashpublications.org/bloodadvances/article/4/19/4693/463998/American-Society-of-Hematology-2020-Guidelines-for

ASH 2020 VTE Guidelines: DVT & PE Treatment For patients with a recurrent unprovoked DVT and/or PE, the ASH guideline panel recommends indefinite antithrombotic therapy over stopping ...