Laguna Thrombectomy System for Pulmonary Embolism

(TRUST Trial)

Recruiting at 18 trial locations

Overseen By Sanjay Shrivastava, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Innova Vascular, Inc.

Must not be taking: Fibrinolytics, Anticoagulants

Disqualifiers: Pregnancy, Chemotherapy, Recent PE, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

107 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device, the Laguna Thrombectomy System, to determine its safety and effectiveness in treating pulmonary embolism (a blood clot in the lungs). The device employs a special clot retriever and aspiration catheter to remove these clots. Individuals with symptoms of pulmonary embolism for up to 14 days and a confirmed blockage in a large lung artery may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to pioneering research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had any fibrinolytic agents (medications that dissolve blood clots) in the last 30 days. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Laguna Thrombectomy System is safe for treating pulmonary embolism?

Research has shown that the Laguna Thrombectomy System is generally safe for people. The CathPCI DELTA study found no major safety issues with aspiration thrombectomy, a component of this system. Patients typically tolerate the device well. Although all medical procedures carry some risk, current evidence indicates that the Laguna Thrombectomy System is safe for treating pulmonary embolism, a blockage in a lung artery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Laguna Thrombectomy System is unique because it offers a mechanical approach to treating pulmonary embolism, a condition traditionally managed with anticoagulant medications or thrombolytic therapy. Unlike these standard treatments, which primarily rely on chemical agents to dissolve blood clots, the Laguna Thrombectomy System physically removes the clot from the pulmonary arteries. This method may reduce the risk of bleeding complications often associated with drug therapies. Researchers are excited because this system has the potential to offer a faster, safer resolution of clots, leading to quicker recovery times for patients.

What evidence suggests that the Laguna Thrombectomy System is effective for pulmonary embolism?

Research shows that the Laguna Thrombectomy System, which participants in this trial will receive, is being tested for its ability to treat pulmonary embolism, a blood clot in the lungs. Early results are promising, as the system uses a method called aspiration to suction out the clot. In one study with 10 patients who had moderate to high-risk pulmonary embolism, the system successfully treated the clots. This suggests the device could effectively remove blood clots from the lungs. More studies are ongoing to confirm these results and assess its safety. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 18-85 with a recent pulmonary embolism (PE), which is a blockage in the lung arteries, can join this trial. They must have certain heart and blood pressure levels and be considered fit for the procedure by a specialist. People are excluded if they don't meet these health criteria or have other conditions not listed here.

Inclusion Criteria

RV/LV ratio > 0.9 as determined by CTA

Heart rate ≤ 120

Patient is deemed eligible for procedure by the interventional investigator

Exclusion Criteria

International Normalized Ratio (INR): > 3

Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments

Presence of recently placed (<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Laguna Thrombectomy procedure for the treatment of pulmonary embolism

1 day

1 visit (in-person)

Immediate Post-procedure Monitoring

Participants are monitored for major adverse events within 48 (± 8) hours post-procedure

2-3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Laguna Thrombectomy System

Trial Overview The TRUST trial is testing the Laguna Thrombectomy System, an experimental device designed to remove clots from lung arteries in patients with PE. It includes two components: the Laguna Clot Retriever™ and Malibu Aspiration Catheter™, both made by Innova Vascular, Inc.

How Is the Trial Designed?

Group I: Laguna Thrombectomy System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Innova Vascular, Inc.

Lead Sponsor

Trials

1

Recruited

110+

Published Research Related to This Trial

The implementation of a consensus-based treatment algorithm (TA) and a PE response team (PERT) significantly increased the use of reperfusion therapy (RT) for pulmonary embolism patients from 4.7% to 16.1% over three periods, indicating improved treatment accessibility.

Patients treated with reduced-dose systemic thrombolysis (SL) experienced no major hemorrhagic complications, and overall hospital stays decreased from an average of 4.78 days to 2.81 days, highlighting the safety and efficacy of the new treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Consensus-Based Pulmonary Embolism Treatment Algorithm and Response Team on Treatment Modality Choices, Outcomes, and Complications. Melamed, R., St Hill, CA., Engstrom, BI., et al.[2021]

In a study of 16 patients with pulmonary embolism (PE) who were not candidates for systemic thrombolysis, rheolytic thrombectomy significantly improved vital signs, with a notable reduction in shock index and mean pulmonary artery pressure after the procedure.

While the procedure was effective for managing massive PE, with some patients experiencing complications, its efficacy for submassive PE needs further investigation to compare it with traditional systemic lytic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pulmonary embolism with rheolytic thrombectomy. Ferrigno, L., Bloch, R., Threlkeld, J., et al.[2021]

From 2013 to 2016, the incidence of adverse events (AEs) in Swedish hospitals decreased from 13.1% to an average of 11.4%, indicating improvements in patient safety during this period.

Preventable AEs were significantly more common (84% more) in patients cared for in inappropriate units ('off-site'), highlighting the importance of proper patient placement and the substantial economic burden of these events, which accounted for 13%-14% of total hospital care costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. Nilsson, L., Borgstedt-Risberg, M., Soop, M., et al.[2019]

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 newly developed thrombectomy device, featuring a self-expandable nitinol basket, successfully extracted between 30% and 95% of thrombus material in sheep models of pulmonary embolism, demonstrating its potential efficacy.

While the device shows promise for extracting emboli, its effectiveness is limited by challenges in maneuverability and positioning within the complex pulmonary arterial system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a newly developed percutaneous thrombectomy basket device in sheep with central pulmonary embolisms. Verma, RK., Pfeffer, JG., Stopinsky, T., et al.[2019]

The Aspirex® mechanical thrombectomy system demonstrated a technical success rate of 75% in treating acute infrainguinal arterial thromboembolic occlusions among 24 patients, indicating its effectiveness in revascularizing occluded vessels.

Clinical success was achieved in all patients (100%), with a 1-year limb salvage rate of 95.8%, suggesting that the device is not only effective but also safe for preventing amputations, although caution is advised for use in smaller distal vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex&#174; mechanical thrombectomy device. Teymen, B., Aktürk, S.[2019]

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

In a study of 54 patients with acute unstable pulmonary embolism, aspiration thrombectomy combined with low-dose catheter-directed thrombolysis significantly reduced mean pulmonary artery pressure from 60.2 mm Hg to 40.5 mm Hg, indicating effective treatment for this life-threatening condition.

The procedure was generally safe, with only one major complication (2.1% risk of hemorrhagic transformation) and minor complications occurring in a small percentage of patients, suggesting a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter-directed aspiration thrombectomy and low-dose thrombolysis for patients with acute unstable pulmonary embolism: Prospective outcomes from a PE registry. De Gregorio, MA., Guirola, JA., Kuo, WT., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06041594

Treating Pulmonary Embolism With Laguna Thrombectomy ... This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary ...

2. withpower.com withpower.com/trial/phase-pulmonary-embolism-11-2023-becfb

Laguna Thrombectomy System for Pulmonary Embolism Patients treated with reduced-dose systemic thrombolysis (SL) experienced no major hemorrhagic complications, and overall hospital stays decreased from an ...

3. trialx.com trialx.com/clinical-trials/listings/323917/treating-pulmonary-embolism-with-laguna-thrombectomy-system-trust/

Treating Pulmonary Embolism With Laguna Thrombectomy ... This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the ...

4. memorialcare.org memorialcare.org/professionals/research-clinical-trials/491-24-study-evaluating-safety-and-effectiveness-using

491-24 | Study Evaluating the safety and effectiveness of ... The Laguna Thrombectomy System may offer an innovative solution to treat a wide range of clots in the peripheral vasculature. Provider.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824010306

Innovation in Catheter-Directed Therapy for Intermediate- ... Preliminary results demonstrated that in 10 patients with intermediate- to high-risk PE, thrombi were treated with aspiration alone, while ...

6. ucihealth.org ucihealth.org/clinical-trials/ccr-24-135

Treating Pulmonary Embolism with Laguna Thrombectomy ... Life expectancy of less than 90 days in the opinion of investigator at the time of enrollment; Subject pregnant or breast feeding; Current ...