107 Participants Needed

Laguna Thrombectomy System for Pulmonary Embolism

(TRUST Trial)

Recruiting at 13 trial locations
SS
Overseen BySanjay Shrivastava, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.311121314

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
See 3 more

Exclusion Criteria

International Normalized Ratio (INR): > 3
Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments
Hematocrit: < 28%
See 21 more

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
1Treatment groups
Experimental Treatment
Group I: Laguna Thrombectomy SystemExperimental Treatment1 Intervention

Find a Clinic Near You

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

References

Effects of a Consensus-Based Pulmonary Embolism Treatment Algorithm and Response Team on Treatment Modality Choices, Outcomes, and Complications. [2021]
Catheter-directed aspiration thrombectomy and low-dose thrombolysis for patients with acute unstable pulmonary embolism: Prospective outcomes from a PE registry. [2020]
Evaluation of a newly developed percutaneous thrombectomy basket device in sheep with central pulmonary embolisms. [2019]
Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex&#174; mechanical thrombectomy device. [2019]
Surgical embolectomy compared to thrombolysis in acute pulmonary embolism: morbidity and mortality. [2022]
Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. [2022]
Comparative Safety of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance of the NCDR CathPCI Registry. [2020]
Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases. [2018]
Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. [2019]
Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily. [2020]
A report of 2 cases of the use of the Inari FlowTriever System in the treatment of pulmonary embolism. [2022]
Right Atrial and Massive Pulmonary Artery Mechanical Thrombectomy Under Echocardiography Guidance Using the FlowTriever System. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
EkoSonic Endovascular System for patients with acute pulmonary embolism and contraindication to systemic fibrinolysis. [2019]
Management of pulmonary embolism with rheolytic thrombectomy. [2021]
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