FlowTriever2 Device for Pulmonary Embolism

(FLARE-FT2 Trial)

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying the FlowTriever2 Catheter, a device designed to remove blood clots from blood vessels. It targets patients who have blood clots that can block blood flow and cause serious health problems. The catheter works by being inserted into the blood vessel to grab and remove the clot, helping to restore normal circulation.

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 data supports the effectiveness of the FlowTriever2 treatment for pulmonary embolism?

Research shows that the FlowTriever device is effective in treating pulmonary embolism by significantly improving pulmonary artery pressure and providing rapid hemodynamic improvement, which means it helps blood flow better in the lungs. It is considered safe and effective for patients with intermediate to high-risk pulmonary embolism, offering an alternative to treatments that have higher bleeding risks. ^{1 2 3 4 5}

Is the FlowTriever2 Device safe for treating pulmonary embolism?

The FlowTriever2 Device has been shown to be generally safe for treating pulmonary embolism, as it allows for the removal of blood clots without the need for clot-dissolving drugs, which can increase bleeding risks. Clinical studies and real-world experiences have demonstrated its safety in treating intermediate-risk and high-risk pulmonary embolism. ^{1 3 4 6 7}

How is the FlowTriever2 treatment for pulmonary embolism different from other treatments?

The FlowTriever2 treatment for pulmonary embolism is unique because it is a mechanical thrombectomy device that removes blood clots without the need for thrombolytic drugs, which can have bleeding risks. This device allows for the nonsurgical removal of clots, offering a safer alternative for patients who may not tolerate traditional drug-based treatments. ^{1 3 4 5 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Completed Cases Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Inari Medical

Lead Sponsor

Trials

18

Recruited

5,300+

Findings from Research

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]

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 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]

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]

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]

References

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

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

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

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

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

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

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

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

7. 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]