Vertex Pulmonary Embolectomy System for Pulmonary Embolism

(SPIRARE II Trial)

Recruiting at 11 trial locations

Overseen By Aadi Chachad

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neptune Medical

Must not be taking: Thrombolytics, Anticoagulants

Disqualifiers: Pulmonary hypertension, Heart failure, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

145 Participants Needed

Trial Summary

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 have used thrombolytics (medications that dissolve blood clots) within 30 days, you cannot participate. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the Vertex Pulmonary Embolectomy System treatment for pulmonary embolism?

Research shows that surgical embolectomy, a procedure to remove blood clots from the lungs, is effective in treating acute massive pulmonary embolism, with improved outcomes in recent years. This suggests that the Vertex Pulmonary Embolectomy System, which is designed for similar purposes, may also be effective. ^{1 2 3 4 5}

How is the Vertex Pulmonary Embolectomy System treatment different from other treatments for pulmonary embolism?

The Vertex Pulmonary Embolectomy System is unique because it likely involves a specialized device or technique for removing blood clots from the lungs, which may offer a less invasive alternative compared to traditional surgical embolectomy that requires open surgery and cardiopulmonary bypass. ^{6 7 8 9 10}

What is the purpose of this trial?

This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.

Research Team

Aadi Chachad

Principal Investigator

Sponsor GmbH

Eligibility Criteria

This trial is for adults aged 18 to 79 with symptoms of acute pulmonary embolism, confirmed by a CT scan showing blockage in major lung arteries. Participants must have stable blood pressure and agree to follow-up visits. It's not suitable for those outside the age range or who can't consent.

Inclusion Criteria

I started having symptoms that could be a lung clot less than 2 weeks ago.

I have a confirmed blood clot in a major lung artery.

My heart's right ventricle is larger than the left, as shown by a scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are treated with the Vertex Pulmonary Embolectomy System for acute pulmonary embolism

48 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vertex Pulmonary Embolectomy System

Trial Overview The study is testing the Vertex Pulmonary Embolectomy System's safety and effectiveness in removing clots from lung arteries in patients with signs of a severe blockage that strains the heart.

Participant Groups

Group I: Vertex Pulmonary Embolectomy System Experimental Treatment 1 Intervention

Patients presenting with clinical signs and symptoms of acute PE and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System

Vertex Pulmonary Embolectomy System is already approved in United States, European Union for the following indications:

Approved in United States as Vertex Pulmonary Embolectomy System for:

• Acute Pulmonary Embolism

Approved in European Union as Vertex Pulmonary Embolectomy System for:

• Acute Pulmonary Embolism

Who Is Running the Clinical Trial?

Neptune Medical

Lead Sponsor

Trials

2

Recruited

160+

Jupiter Endovascular

Lead Sponsor

Findings from Research

Pulmonary embolectomy is a safe and effective treatment for massive pulmonary embolism, achieving a 95% survival rate in a study of 20 patients with significant preoperative comorbidities and right ventricular dysfunction.

The procedure is recommended early in treatment for patients with submassive pulmonary embolism to prevent worsening conditions, even in those experiencing hemodynamic instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary embolectomy in the treatment of submassive and massive pulmonary embolism. Worku, B., Gulkarov, I., Girardi, LN., et al.[2019]

Open pulmonary embolectomy is shown to be the most effective treatment for acute massive pulmonary embolism, based on a review of 11 patients over a 7-year period.

Cardiac arrest before surgery is a significant negative prognostic factor, but even in such cases, some patients can survive, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical embolectomy in acute massive pulmonary embolism. Amirghofran, AA., Emami Nia, A., Javan, R.[2017]

In a study of 58,974 patients with acute pulmonary embolism, surgical embolectomy showed a mortality rate of 19.8%, indicating improved outcomes compared to traditional experiences, especially for high-risk patients.

Patients undergoing surgical embolectomy had more severe conditions, such as saddle emboli and higher risks of death, but the study supports the role of surgery as part of a multidisciplinary approach to treating this serious condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Outcomes of Surgical Embolectomy for Acute Pulmonary Embolism. Percy, ED., Shah, R., Hirji, S., et al.[2020]

In a study comparing 108 patients with acute massive pulmonary embolism, surgical embolectomy showed a significantly greater improvement in right ventricular diameter and systolic pulmonary artery pressure compared to thrombolytic therapy after three days.

Although the mortality rate was lower in the surgical group, the difference was not statistically significant, suggesting that while surgery may reduce complications, both treatments are critical for managing this serious condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. Azari, A., Beheshti, AT., Moravvej, Z., et al.[2022]

Surgical pulmonary embolectomy for acute pulmonary embolism shows a 19% in-hospital mortality rate, with significant risk factors for in-hospital mortality including age over 70, small body surface area, preoperative resuscitation, and absence of deep vein thrombosis.

The 10-year survival rate for patients who survived to discharge is 66.4%, indicating that surgical embolectomy can lead to favorable long-term outcomes, particularly for younger patients and those with pulmonary embolism linked to deep vein thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term outcomes for the surgical treatment of acute pulmonary embolism. Dohle, K., Dohle, DS., El Beyrouti, H., et al.[2022]

In a study of 22 patients undergoing surgical embolectomy for pulmonary embolism, the procedure showed a significant difference in mortality rates, with 44.4% in those with massive pulmonary embolism and cardiogenic shock compared to only 7.7% in stable patients.

The use of retrograde perfusion during surgery allowed for the effective removal of emboli from both major and peripheral pulmonary branches, suggesting that advancements in surgical techniques can improve outcomes and broaden the criteria for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of pulmonary embolism]. Nemec, P., Uchytil, B., Cerný, J., et al.[2009]

Transvenous pulmonary embolectomy using a vacuum-cupped catheter has shown immediate and significant improvement in hemodynamic function for patients with acute massive pulmonary embolism.

The simultaneous insertion of an intracaval filter during the procedure offers additional protection against the risk of recurrent thromboembolism, enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvenous pulmonary embolectomy for acute massive pulmonary embolism. Scoggins, WG., Greenfield, LJ.[2019]

In a review of 6 patients who underwent pulmonary embolectomy for massive pulmonary embolism, the procedure was found to be effective, with 5 out of 6 patients surviving, highlighting its potential life-saving capability.

The study emphasizes the importance of aggressive surgical intervention using cardiopulmonary bypass, along with postoperative anticoagulation therapy, to prevent recurrent embolism and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of massive pulmonary embolism--the time of the operation and its effectiveness]. Hara, H., Aoyagi, S., Hirata, Y., et al.[2011]

Surgical pulmonary embolectomy is an effective treatment for massive pulmonary embolism, and the use of video assistance has been recently adopted to improve visualization during the procedure.

This strategy enhances the clearance of distal pulmonary emboli, potentially leading to better patient outcomes, although specific results and data from the experience were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video assistance for surgical pulmonary embolectomy. Pawale, A., Seetharam, K., Oswald, E., et al.[2018]

The dedicated pigtail catheter system successfully recanalized 55% of pulmonary embolic occlusions in an animal study involving ten dogs, demonstrating its efficacy in treating pulmonary embolism.

The catheter's embolus fragmentation technique significantly reduced the increase in pulmonary arterial pressure by 72%, indicating its potential to improve hemodynamic stability during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diagnosis and fragmentation therapy of acute massive pulmonary embolism with a rotatable pigtail catheter: experimental studies]. Schmitz-Rode, T., Günther, RW., Neuerburg, J., et al.[2016]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pulmonary embolectomy in the treatment of submassive and massive pulmonary embolism. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Surgical embolectomy in acute massive pulmonary embolism. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

National Outcomes of Surgical Embolectomy for Acute Pulmonary Embolism. [2020]

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

Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. [2022]

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

Short- and long-term outcomes for the surgical treatment of acute pulmonary embolism. [2022]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Surgical treatment of pulmonary embolism]. [2009]

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

Transvenous pulmonary embolectomy for acute massive pulmonary embolism. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[Surgical treatment of massive pulmonary embolism--the time of the operation and its effectiveness]. [2011]

9. Germany pubmed.ncbi.nlm.nih.gov

Video assistance for surgical pulmonary embolectomy. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

[The diagnosis and fragmentation therapy of acute massive pulmonary embolism with a rotatable pigtail catheter: experimental studies]. [2016]