Clinical trial NCT06571760: Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
Official title: Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Embolism and Thrombosis
Pulmonary Embolism
Embolism
Cardiovascular Diseases
Lead sponsor: Neptune Medical
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study 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 pulmonary embolism.

Detailed description: The 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.

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.

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 is willing and able to provide written informed consent prior to receiving any non-standard of care clinical investigation plan specific procedures
7. Subject is willing and able to comply with all clinical investigation plan 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

Primary outcomes:
measure: Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio
timeFrame: From baseline to 48 hours or discharge
measure: Major Adverse Events (AEs), a composite of:
timeFrame: Within 48 hours of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH Vienna - Medical university of Vienna
city: Kraków
country: Poland
facility: Jagiellonian University
Study officials:
affiliation: Sponsor GmbH
name: Aadi Chachad
role: STUDY_DIRECTOR
References: