Non-surgical removal of blood clots from the lungs

Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II

This study is testing a new non-surgical method to remove blood clots from the lungs to see if it helps people with acute pulmonary embolism feel better and stay safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Jupiter Endovascular (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 12 sites (Hartford, Connecticut and 11 other locations)
• Trial ID: NCT06576427 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Vertex Pulmonary Embolectomy System in patients with acute pulmonary embolism. It is a prospective, single-arm, multicenter study where participants will undergo a non-surgical procedure to remove emboli and thrombi from their pulmonary arteries. The study aims to assess clinical outcomes and the system's ability to alleviate symptoms associated with pulmonary embolism. Participants will be monitored for safety and effectiveness throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who exhibit acute symptoms of pulmonary embolism within the last 14 days and have specific imaging evidence of the condition.

Not a fit: Patients with recent thrombolytic treatment or severe pulmonary hypertension may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve treatment outcomes for patients suffering from acute pulmonary embolism.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the treatment of pulmonary embolism, indicating potential for success.

Eligibility criteria

Inclusion Criteria

1. Age ≥ 18 years \< 80 years
2. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
4. RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined).
5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
6. Subject or subject's legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care Protocol-specific procedures
7. Subject is willing and able to comply with all Protocol-required follow-up visits

Exclusion Criteria

1. Thrombolytic use within 30 days of baseline CTA
2. Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined)
3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
4. Unstable heart rate \> 130 beats per minute prior to procedure
5. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
6. Hematocrit \< 28%
7. Platelets \< 100,000/μL
8. Serum baseline creatinine \> 1.8 mg/dL
9. International normalized ratio (INR) \> 3
10. Major trauma injury severity score (ISS) \> 15 within the past 14 days
11. Presence of intracardiac lead in the right ventricle or right atrium placed \<180 days prior to the index procedure
12. Cardiovascular or pulmonary surgery within last 30 days
13. Actively progressing cancer requiring chemotherapy
14. Known bleeding diathesis or coagulation disorder
15. Left bundle branch block
16. History of severe or chronic pulmonary arterial hypertension
17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
18. History of decompensated heart failure
19. Patients on extracorporeal membrane oxygenation (ECMO)
20. History of underlying lung disease that is oxygen dependent
21. History of chest irradiation
22. History of heparin-induced thrombocytopenia (HIT)
23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants
24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention
26. Life expectancy of \< 365 days, as determined by Investigator
27. Female who is pregnant or nursing
28. Current participation in another investigational drug or device treatment study
29. Inability to lay flat for procedure
30. Known presence of right-to-left cardiac shunt
31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Where this trial is running

Hartford, Connecticut and 11 other locations

• Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
• Ascension Sacred Heart — Pensacola, Florida, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• Cardiovascular Institute of the South — Houma, Louisiana, United States (Recruiting)
• Northwell Health — Staten Island, New York, United States (Recruiting)
• University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
• Upmc — Harrisburg, Pennsylvania, United States (Recruiting)
• Penn Presbyterian — Philadelphia, Pennsylvania, United States (Recruiting)
• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (Recruiting)
• Musc — Charleston, South Carolina, United States (Recruiting)
• Baylor Scott & White — Plano, Texas, United States (Recruiting)
• Carilion — Roanoke, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Karlee Hunter

Conditions Pulmonary Embolism; Embolism and Thrombosis; Embolism; Cardiovascular Diseases