Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
United States123 participantsStarted 2024-10-15
Plain-language summary
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. . Age ≥ 18 years \< 80 years
✓. Acute onset of symptoms \< 14 days consistent with the presence of pulmonary embolism.
✓. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
✓. RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined).
✓. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
✓. Subject or subject's legally authorized representative (LAR) - applicable for US is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan-specific procedures
✓. Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visits
Exclusion criteria
✕. Thrombolytic use within 30 days of baseline CTA
✕. Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined)
✕. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
✕. Unstable heart rate \> 130 beats per minute prior to procedure
✕. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
What they're measuring
1
Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio