Akura Thrombectomy System for Pulmonary Embolism

Recruiting at 10 trial locations

Overseen By Rukhsana Khanum

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Akura Medical

Must not be taking: Thrombolytics, Chemotherapeutics

Disqualifiers: Pulmonary hypertension, Heart failure, Cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with a recent pulmonary embolism (PE), a blood clot in the lungs. The researchers aim to determine if the Akura Thrombectomy System, a device that removes clots, is safe and effective. Suitable participants have experienced PE symptoms for two weeks or less and have evidence of a clot in the lung's main arteries on a CT scan. As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research that could enhance future PE treatments.

Will I have to stop taking my current medications?

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

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

A previous study found the Akura Thrombectomy System safe for treating pulmonary embolism (a blockage in the blood vessels of the lungs). The treatment effectively removed clots from the lungs, improving heart function. The study reported no major safety issues, suggesting the system is well-tolerated.

For those considering joining a trial, this information can clarify the treatment's safety. Always discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Akura Thrombectomy System because it offers a novel approach to treating acute pulmonary embolism by using mechanical thrombectomy. Unlike the standard care options, which often include anticoagulant medications like heparin or thrombolytics, the Akura System physically removes the clot from the blood vessels, potentially providing faster relief of symptoms. This direct removal of the clot can be particularly beneficial in urgent situations, as it may improve blood flow more quickly and reduce the risk of long-term complications.

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

Research has shown that the Akura Thrombectomy System, used by participants in this trial, might effectively treat sudden blood clots in the lungs, known as acute pulmonary embolism (PE). One study found that it reduced heart strain within 48 hours after the procedure, indicating that the heart may start functioning better soon after treatment. Additionally, compared to some other treatments, it carries a lower risk of causing major bleeding or recurrence of the blood clot. These findings suggest that the Akura Thrombectomy System could be a promising option for people with acute PE. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with acute pulmonary embolism (PE), showing symptoms for less than two weeks. They must have a CT scan showing a blockage in the main lung arteries and an enlarged right side of the heart compared to the left. Their blood pressure and heart rate must be within certain limits.

Inclusion Criteria

CTA evidence of RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)

Systolic BP ≥ 90 mmHg (initial SBP may be < 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)

I am over 18 and fit for surgery as per my doctor's advice.

Exclusion Criteria

My heart's pulmonary pressure is above 70 mmHg.

Prior PE <180 days from index procedure

CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo mechanical thrombectomy using the Akura Thrombectomy System for acute pulmonary embolism

Immediate procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, including changes in RV/LV ratio and major adverse device-related events

48 hours

1 visit (in-person)

Extended Follow-up

Assessment of major adverse events through 30-day follow-up

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Akura Thrombectomy System

Trial Overview The study tests the Akura Thrombectomy System, a device designed to mechanically remove clots from lung arteries in patients with acute PE. It's an observational study where all participants receive this intervention without comparison to another treatment.

How Is the Trial Designed?

Group I: Patients with Acute Pulmonary Embolism Experimental Treatment 1 Intervention

Patients undergoing mechanical thrombectomy for acute pulmonary embolism.

Who Is Running the Clinical Trial?

Akura Medical

Lead Sponsor

Trials

3

Recruited

160+

Published Research Related to This Trial

The overall rate of perioperative adverse events (AEs) in thoracic surgery was low at 0.2%, with the majority of AEs caused by surgical factors (55.3%) and anaesthesia-related factors (23.3%), indicating that while AEs are infrequent, they are often linked to critical aspects of the surgical process.

Sudden cardiac arrest and massive hemorrhage were the two major clinical manifestations of AEs, with timely identification and treatment being crucial for improving patient outcomes, as 8% of patients with AEs died within 3 days, primarily due to massive hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of 62,571 cases of perioperative adverse events in thoracic surgery at a tertiary care teaching hospital in a developing country. Li, Q., Zhang, X., Xu, M., 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]

Catheter-directed therapy (CDT) significantly reduced in-hospital mortality compared to systemic thrombolysis (ST), anticoagulation (AC), and surgical embolectomy (SE) in patients with intermediate to high-risk pulmonary embolism, based on a network meta-analysis of 11 RCTs and 42 observational studies involving 157,454 patients.

CDT also showed a lower rate of recurrent pulmonary embolism compared to ST and AC, while presenting a lower risk of major bleeding compared to ST and AC, indicating it may be a safer and more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of interventions for intermediate to high-risk pulmonary embolism: A network meta-analysis. Ishisaka, Y., Watanabe, A., Fujisaki, T., et al.[2023]

Reperfusion therapy is crucial for treating high-risk pulmonary embolism patients, with systemic thrombolysis being effective but associated with a higher risk of bleeding.

Emerging catheter-based reperfusion therapies show similar efficacy to systemic thrombolysis but with a better safety profile, making them a promising option for intermediate-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reperfusion Treatment for Acute Pulmonary Embolism. Engelberger, RP., Kucher, N.[2019]

The EKOS EkoSonic ultrasound system was successfully used to treat a 69-year-old female with a massive pulmonary embolism and a large mobile right atrial thrombus, leading to complete resolution of the thrombus.

This case highlights the effectiveness of catheter-directed lysis with ultrasound and tissue plasminogen activator as a new treatment option for serious cases of right atrial thrombus associated with pulmonary embolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-assisted lysis using recombinant tissue plasminogen activator and the EKOS EkoSonic endovascular system for treating right atrial thrombus and massive pulmonary embolism: A case study. Shammas, NW., Padaria, R., Ahuja, G.[2016]

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]

Thrombolytic therapy significantly reduces the in-hospital all-cause case fatality rate in unstable patients with acute pulmonary embolism, with a fatality rate of 15% compared to 47% in those who did not receive the treatment.

The combination of thrombolytic therapy and a vena cava filter further decreases the case fatality rate, showing only 2.7% mortality compared to 27% with a filter alone, indicating that this combination is highly effective for these high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. Stein, PD., Matta, F.[2022]

In a study of 25 patients with high-risk acute pulmonary embolism (aPE) treated with pulmonary embolectomy, the use of a comprehensive therapeutic algorithm, including extracorporeal life support (ECLS), showed that this approach can be effective, with a 20% in-hospital mortality rate.

Preoperative cardiac arrest significantly increased the risk of in-hospital mortality, highlighting the critical need for timely intervention, even with ECLS support, while no late deaths or recurrences were observed during a median follow-up of 19 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary embolectomy in high-risk acute pulmonary embolism: the effectiveness of a comprehensive therapeutic algorithm including extracorporeal life support. Wu, MY., Liu, YC., Tseng, YH., et al.[2013]

Acute pulmonary embolism (PE) is a serious condition affecting over 100,000 people annually in the U.S., and while standard treatment involves anticoagulation, some patients require more advanced interventions due to severe symptoms.

Recent advancements in catheter-based therapies, such as catheter-directed thrombolysis and suction thrombectomy, offer targeted treatment options that can improve outcomes for patients with acute PE, emphasizing the importance of a multidisciplinary approach in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Management of Acute Pulmonary Embolism: Evolution of Catheter-based Therapy. Carlon, TA., Goldman, DT., Marinelli, BS., et al.[2022]

Mechanical thrombectomy using the Amplatz thrombectomy device (ATD) was successfully performed on nine patients with acute pulmonary embolism, showing a significant reduction in thrombus and improvement in pulmonary arterial pressure.

The procedure was found to be technically feasible and safe, suggesting that it could serve as an alternative to traditional drug therapies and surgery, although further randomized controlled studies are needed to confirm its advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy of major and massive pulmonary embolism with use of the Amplatz thrombectomy device. Müller-Hülsbeck, S., Brossmann, J., Jahnke, T., et al.[2019]

AngioJet Rheolytic Thrombectomy (ART) demonstrated a high technical and clinical success rate of 91.67% in treating acute pulmonary embolism (APE) in a study of 12 patients followed for 6-32 months.

Post-treatment, patients showed significant improvements, including increased arterial oxygen levels and decreased levels of hemoglobin and troponin, indicating effective thrombus clearance and improved long-term outcomes without recurrence of APE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of the Safety and Efficacy of AngioJet Rheolytic Thrombectomy for Acute Pulmonary Embolism: A Single-Center Study. Shi, S., Li, C., Zhang, Q., et al.[2023]

In a study of 488 patients who underwent elective lung surgery, those with no adverse events (AEs) had a median hospital stay of 2 days, while those with minor and major AEs had median stays of 4 and 8 days, respectively, indicating that AEs significantly prolong hospital stays.

The study found that 11.9% of patients were readmitted to the hospital, with readmission rates significantly associated with the presence of AEs, highlighting the impact of postoperative complications on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Major and Minor Complications After Lung Surgery on Length of Stay and Readmission. Finley, CJ., Begum, HA., Pearce, K., et al.[2022]

In a study of eight patients with acute massive pulmonary embolism, on-pump beating pulmonary embolectomy proved to be an effective treatment, with seven out of eight patients successfully rescued after surgery.

Despite one patient experiencing complications, the procedure showed a low rate of major complications during an average follow-up of 11.4 months, suggesting it is a viable option for critically ill patients who do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[On-pump Beating Pulmonary Embolectomy for Acute Pulmonary Thromboembolism]. Kawakami, A., Kobayashi, Y., Shiraki, H., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06362928

Safety and Effectiveness of the Akura Thrombectomy ... This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous ...

2. withpower.com withpower.com/trial/phase-pulmonary-embolism-11-2024-20e7f

Akura Thrombectomy System for Pulmonary Embolism CDT also showed a lower rate of recurrent pulmonary embolism compared to ST and AC, while presenting a lower risk of major bleeding compared to ST and AC, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11635272/

Research progress in interventional therapy for acute ... They account for 40–65% of all patients with PE, and their 30-day mortality rate is approximately 1%. When treating patients with low-risk PE, outpatient ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06672510

NCT06672510 | Safety and Effectiveness of the Akura ... This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy.

5. evtoday.com evtoday.com/news/akura-begins-pivotal-trial-of-katana-thrombectomy-system-in-pulmonary-embolism

Akura Begins Pivotal Trial of Katana Thrombectomy ... The primary effectiveness endpoint is the reduction in right ventricular/left ventricular ratio from baseline to 48 hours post procedure as ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06672510

NCT06672510 | Safety and Effectiveness of the Akura ... This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy ...

7. vascularnews.com vascularnews.com/akura-thrombectomy-system-for-pe-appears-safe-and-demonstrates-reduction-of-rv-lv-ratio-in-first-in-human-study/

Akura thrombectomy system for PE appears safe and ... The patients successfully received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature.