Symphony Thrombectomy for Pulmonary Embolism

Recruiting at 18 trial locations

Overseen By Sameh Sayfo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Imperative Care, Inc.

Must not be taking: Thrombolytics, Anticoagulants, Chemotherapy

Disqualifiers: Kidney dysfunction, Cardiac arrest, Cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

109 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have used thrombolytics (clot-dissolving drugs) within 14 days before the baseline CTA (a type of imaging test).

Is the Symphony Thrombectomy System safe for treating pulmonary embolism?

The safety of percutaneous thrombectomy (a procedure to remove blood clots) for pulmonary embolism was evaluated in a study, showing a 4% rate of major bleeding events and comparable mortality rates to other treatments. This suggests it is generally safe, especially for patients who cannot use other clot-busting drugs. ^{1 2 3 4 5}

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

The Symphony Thrombectomy System is a mechanical treatment that physically removes blood clots from the lungs, offering an alternative to systemic thrombolysis (using drugs to dissolve clots) which can have bleeding risks. Unlike surgical embolectomy, which is invasive and high-risk, this system provides a less invasive option for patients with pulmonary embolism. ^{5 6 7 8 9}

Eligibility Criteria

This trial is for adults aged 18-80 with recent pulmonary embolism (PE), confirmed by CTA, who have symptoms of PE and a stable blood pressure and heart rate. Participants must have an enlarged right ventricle but be in a stable condition to give consent and follow the study protocol.

Inclusion Criteria

Your heart rate was stable and below 130 beats per minute prior to the procedure.

I am showing signs of a possible pulmonary embolism.

My blood pressure is at least 90 mmHg and I have a heart condition where my right ventricle is enlarged.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Symphony Thrombectomy System

Trial Overview The Symphony Thrombectomy System is being tested for safety and effectiveness in removing blood clots from the lungs (pulmonary embolism). This device aims to improve cardiovascular health by treating these potentially life-threatening clots.

Participant Groups

Group I: Symphony Thrombectomy system Experimental Treatment 1 Intervention

Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.

Symphony Thrombectomy System is already approved in United States for the following indications:

Approved in United States as Symphony Thrombectomy System for:

• Peripheral vascular disease
• Deep vein thrombosis

Who Is Running the Clinical Trial?

Imperative Care, Inc.

Lead Sponsor

Trials

2

Recruited

480+

Findings from Research

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® mechanical thrombectomy device. Teymen, B., Aktürk, S.[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]

Percutaneous thrombectomy (PT) is a safe and effective treatment for patients with intermediate- and high-risk pulmonary embolism (PE) who cannot receive thrombolytics, showing low in-hospital and 30-day mortality rates of 4% and 5%, respectively, based on a meta-analysis of 17 studies involving 455 patients.

The procedure significantly reduced pulmonary arterial pressures and improved heart function, with only a 4% incidence of major bleeding events, indicating that PT can be a viable option for patients at risk of bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous thrombectomy in patients with intermediate- and high-risk pulmonary embolism and contraindications to thrombolytics: a systematic review and meta-analysis. Milioglou, I., Farmakis, I., Wazirali, M., et al.[2023]

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]

Surgical embolectomy for acute pulmonary embolism (PE) was performed on 33 patients, showing a low 30-day mortality rate of 6%, indicating it can be a safe option for high-risk patients.

The long-term survival rate was 80% over 12 years, supporting the procedure's role as an important treatment option for patients with severe PE, especially those who cannot undergo thrombolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of acute pulmonary embolism--a 12-year retrospective analysis. Lehnert, P., Møller, CH., Carlsen, J., et al.[2012]

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]

This study analyzed the outcomes of surgical pulmonary embolectomy (SPE) for acute pulmonary emboli in 214 patients across four high-volume institutions, showing that the procedure is safe with an in-hospital mortality rate of only 11.7%.

SPE is effective for both massive and submassive pulmonary emboli, suggesting it should be considered as a treatment option in the management of life-threatening pulmonary emboli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes After Surgical Pulmonary Embolectomy for Acute Pulmonary Embolus: A Multi-Institutional Study. Keeling, WB., Sundt, T., Leacche, M., et al.[2022]

In a study of 45 patients with acute massive pulmonary embolism, surgical embolectomy (SE) was associated with a significantly lower risk of cardiac mortality compared to thrombolysis (TL), suggesting SE may be a better first-line treatment for certain patients.

The overall 30-day all-cause mortality rate was 24%, with no significant difference between SE (15%) and TL (37%) groups, but TL was identified as an independent predictor of cardiac death, highlighting the potential risks associated with thrombolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of acute massive pulmonary embolism: Is surgical embolectomy inferior to thrombolysis? Cho, YH., Sung, K., Kim, WS., et al.[2022]

Mechanical thrombectomy (MT) for acute pulmonary embolism (PE) resulted in significantly lower in-hospital mortality (11.9%) compared to systemic thrombolysis (ST) (20.6%), suggesting MT may be a safer alternative for certain patients.

Despite the lower mortality with MT, patients experienced a higher rate of respiratory complications and were more likely to be discharged to outside facilities, indicating that while MT is effective, careful patient selection is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Mechanical Thrombectomy Compared With Systemic Thrombolysis in Pulmonary Embolism: A Comprehensive Evaluation From the National Inpatient Sample Database. Al-Khadra, Y., Missula, V., Al-Bast, B., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex® mechanical thrombectomy device. [2019]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Percutaneous thrombectomy in patients with intermediate- and high-risk pulmonary embolism and contraindications to thrombolytics: a systematic review and meta-analysis. [2023]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Surgical treatment of acute pulmonary embolism--a 12-year retrospective analysis. [2012]

6. Egypt pubmed.ncbi.nlm.nih.gov

Management of pulmonary embolism with rheolytic thrombectomy. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes After Surgical Pulmonary Embolectomy for Acute Pulmonary Embolus: A Multi-Institutional Study. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Management of acute massive pulmonary embolism: Is surgical embolectomy inferior to thrombolysis? [2022]

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

Outcomes of Mechanical Thrombectomy Compared With Systemic Thrombolysis in Pulmonary Embolism: A Comprehensive Evaluation From the National Inpatient Sample Database. [2022]