Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
NCT ID: NCT06576427
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
145 participants
INTERVENTIONAL
2024-10-15
2026-03-31
Brief Summary
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Detailed Description
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The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vertex Pulmonary Embolectomy System
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
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Interventions
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Vertex Pulmonary Embolectomy System
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
79 Years
ALL
No
Sponsors
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Jupiter Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Aadi Chachad
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Emory University
Atlanta, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford St John
Detroit, Michigan, United States
NYU Langone Health
New York, New York, United States
Northwell Health
Staten Island, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Penn Presbyterian
Philadelphia, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
St Clair Health
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Baylor Scott & White
Plano, Texas, United States
Carilion
Roanoke, Virginia, United States
Medical University of Vienna
Vienna, , Austria
St. John Paul II Hospital
Krakow, , Poland
European Health Center Otwock
Otwock, , Poland
University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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CSP-02
Identifier Type: -
Identifier Source: org_study_id