Akura Thrombectomy System for Pulmonary Embolism

Recruiting at 6 trial locations

Overseen By Bryan Wylie

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

Trial Summary

What is the purpose of this trial?

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).

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

The research highlights that catheter-based therapies, like suction thrombectomy, are evolving and show promise in treating pulmonary embolism by mechanically removing clots from the arteries. This approach is considered effective and safer compared to traditional methods, as it avoids the use of clot-dissolving drugs that can increase bleeding risk. ^{1 2 3 4 5}

Is the Akura Thrombectomy System safe for treating pulmonary embolism?

The safety of catheter-directed aspiration thrombectomy, which may be similar to the Akura Thrombectomy System, has been evaluated in combination with low-dose thrombolysis for treating pulmonary embolism. However, the specific safety data for the Akura Thrombectomy System itself is not detailed in the available research. ^{6 7 8 9 10}

How does the Akura Thrombectomy System treatment for pulmonary embolism differ from other treatments?

The Akura Thrombectomy System is unique because it is a steerable and quickly placeable device designed for mechanical removal of clots in cases of extensive pulmonary embolism, unlike traditional treatments that often rely on medication to dissolve clots or require open surgery. ^{1 5 11 12 13}

Eligibility Criteria

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)

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

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

Exclusion Criteria

My heart's pulmonary pressure is above 70 mmHg.

Prior PE <180 days from index procedure

My heart's pumping ability is significantly reduced.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

Contemporary Management of Acute Pulmonary Embolism: Evolution of Catheter-based Therapy. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

[On-pump Beating Pulmonary Embolectomy for Acute Pulmonary Thromboembolism]. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Reperfusion Treatment for Acute Pulmonary Embolism. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary embolectomy in high-risk acute pulmonary embolism: the effectiveness of a comprehensive therapeutic algorithm including extracorporeal life support. [2013]

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

Mechanical thrombectomy of major and massive pulmonary embolism with use of the Amplatz thrombectomy device. [2019]

6. 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]

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

Comparison of interventions for intermediate to high-risk pulmonary embolism: A network meta-analysis. [2023]

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

Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. [2022]

9. England 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. [2020]

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

The Effect of Major and Minor Complications After Lung Surgery on Length of Stay and Readmission. [2022]

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

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

12. England 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. [2016]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of the Safety and Efficacy of AngioJet Rheolytic Thrombectomy for Acute Pulmonary Embolism: A Single-Center Study. [2023]