FlowTriever2 Device for Pulmonary Embolism

(FLARE-FT2 Trial)

No longer recruiting at 6 trial locations

Overseen By Rae Besser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inari Medical

Must not be taking: Thrombolytics, Vasopressors

Disqualifiers: Pulmonary hypertension, Cancer, Heart failure, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the FlowTriever2 Catheter, a device designed to remove blood clots from the lungs in people with a pulmonary embolism (a blood clot blocking blood flow in the lungs). The study will evaluate the device's effectiveness and safety for this condition. Suitable candidates for the trial have experienced pulmonary embolism symptoms for less than 14 days and have a confirmed clot in the lung's main or lobar artery. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance treatment options for pulmonary embolism.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used thrombolytics (medications that dissolve blood clots) within 30 days before the trial's baseline scan.

What prior data suggests that the FlowTriever2 Catheter is safe for pulmonary embolism treatment?

Research has shown that the FlowTriever2 Catheter is safe for treating pulmonary embolism (PE). One study found that the FlowTriever system, which includes the FlowTriever2 Catheter, serves as a safe alternative to other treatments and effectively removes blood clots from the lungs. Another study demonstrated its effectiveness even for patients who cannot take certain blood-thinning medications.

The largest study to date examined its safety and reported positive results after use. This indicates that the FlowTriever2 Catheter is generally well-tolerated, with a low risk of serious side effects. Overall, current evidence supports the FlowTriever2 Catheter as a safe option for patients with PE. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FlowTriever2 Catheter is unique because it offers a mechanical approach to treating pulmonary embolism, which is a blockage in the lung's arteries often addressed by blood thinners or clot-dissolving drugs. Unlike these standard medications, the FlowTriever2 uses a catheter-based system to physically remove the clot, potentially providing faster relief and reducing the risk of bleeding complications. Researchers are excited about this treatment because it targets the clot directly, offering a promising alternative for patients who may not respond well to traditional drug therapies.

What evidence suggests that the FlowTriever2 Catheter is effective for pulmonary embolism?

Research has shown that the FlowTriever2 Catheter effectively treats pulmonary embolism (PE), a condition where blood clots block blood flow in the lungs. In past studies, this device effectively removed these clots, helping blood flow return to normal. One study found that using the FlowTriever system in patients with severe PE led to a lower death rate than expected for such serious cases. Another study demonstrated that the device is generally safe and improves health outcomes for patients with severe PE. These results suggest that the FlowTriever2 Catheter is a promising treatment option for this condition. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with a recent pulmonary embolism (PE), which is a blockage in the lungs. They should have symptoms for less than 14 days, an unstable heart rate, and evidence of PE on a CT scan. Participants must not be pregnant or nursing, have severe other illnesses like active cancer or bleeding disorders, or be on certain medications that could increase risks.

Inclusion Criteria

My doctor thinks I am fit for a medical procedure.

My symptoms of pulmonary embolism have been present for 2 weeks or less.

Your heart's right ventricle is significantly larger than the left ventricle.

Exclusion Criteria

I have a history of heart failure that is not well-managed.

Your blood test shows that your creatinine level is higher than 1.8 mg/dL.

My cancer is getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the FlowTriever2 Catheter procedure

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for mortality and major bleeding occurrences

48 hours

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and recurrence of pulmonary embolism

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FlowTriever2 Catheter

Trial Overview The FlowTriever2 Catheter is being tested to see if it can safely remove blood clots from the lungs in patients with PE. This study involves one group of participants who will all receive this treatment without comparison to another intervention.

How Is the Trial Designed?

Group I: All Subjects Experimental Treatment 1 Intervention

All participants who were treated with the FlowTriever System and FlowTriever2 Catheter.

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05560763

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 thrombectomy in ...

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695530/

Catheter-directed therapy with the FlowTriever system for ... In the largest analysis of high-risk PE patients to date, a mortality rate of 20.6% was reported [6]. The first-choice reperfusion therapy in ...

4. 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 ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/63/NCT05560763/Prot_000.pdf

FlowTriever Pulmonary Embolectomy Clinical Study- ... Study Objective. The primary study objective is to evaluate the safety and effectiveness of the. FlowTriever2 Catheter for the treatment of pulmonary embolism ( ...

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

FlowTriever® system for the treatment of pulmonary ... The FlowTriever system is designed for rapid thrombus removal and immediate symptom improvement for patients suffering from acute pulmonary embolism.

7. americanjir.com americanjir.com/safety-of-the-inari-flowtriever-device-for-mechanical-thrombectomy-in-patients-with-acute-submassive-and-massive-pulmonary-embolism-and-contraindication-to-thrombolysis/

Safety of the Inari FlowTriever device for mechanical ... FlowTriever mechanical thrombectomy appears safe for acute PE in therapeutically anticoagulated patients with contraindications to thrombolytic therapy.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02692586

FlowTriever Pulmonary Embolectomy Clinical Study Study Overview. Brief Summary. Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries ...