Laguna Thrombectomy System for Pulmonary Embolism

(TRUST Trial)

Recruiting at 13 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

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.

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 data supports the effectiveness of the Laguna Thrombectomy System treatment for pulmonary embolism?

The research suggests that catheter-directed interventions, like the Laguna Thrombectomy System, can be effective for treating pulmonary embolism, as similar treatments have shown improved patient outcomes and reduced hospital stays. Additionally, the use of aspiration thrombectomy combined with low-dose thrombolysis has been evaluated for safety and efficacy in treating acute unstable pulmonary embolism. ^{1 2 3 4 5}

Is the Laguna Thrombectomy System generally safe for use in humans?

The CathPCI DELTA study found no significant safety concerns for aspiration thrombectomy catheters, similar to the Laguna Thrombectomy System, in terms of death or major adverse cardiovascular events during hospital stays. ^{6 7 8 9 10}

How is the Laguna Thrombectomy System treatment different from other treatments for pulmonary embolism?

The Laguna Thrombectomy System is unique because it likely offers a mechanical approach to removing blood clots in the lungs, similar to the Inari FlowTriever System, which removes clots without the need for clot-dissolving drugs, reducing the risk of bleeding associated with those medications. ^{3 11 12 13 14}

Eligibility Criteria

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

Hematocrit: < 28%

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Laguna Thrombectomy System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Innova Vascular, Inc.

Lead Sponsor

Trials

1

Recruited

110+

Findings from Research

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 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]

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]

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]

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]

References

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

Effects of a Consensus-Based Pulmonary Embolism Treatment Algorithm and Response Team on Treatment Modality Choices, Outcomes, and Complications. [2021]

2. Netherlands 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. [2020]

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

Evaluation of a newly developed percutaneous thrombectomy basket device in sheep with central pulmonary embolisms. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

Surgical embolectomy compared to thrombolysis in acute pulmonary embolism: morbidity and mortality. [2022]

6. Switzerland 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. [2022]

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

Comparative Safety of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance of the NCDR CathPCI Registry. [2020]

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

Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases. [2018]

9. England 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. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily. [2020]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

Right Atrial and Massive Pulmonary Artery Mechanical Thrombectomy Under Echocardiography Guidance Using the FlowTriever System. [2022]

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

EkoSonic Endovascular System for patients with acute pulmonary embolism and contraindication to systemic fibrinolysis. [2019]

14. Egypt pubmed.ncbi.nlm.nih.gov

Management of pulmonary embolism with rheolytic thrombectomy. [2021]