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

Completed · Not applicable

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT06576427

Run by

Jupiter Endovascular

People needed

123

Starts

2024-10-15

Expected to finish

2026-03-03

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• . 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

You may not qualify if…

• 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%
• Hematocrit < 28%
• Platelets < 100,000/μL
• Serum baseline creatinine > 1.8 mg/dL
• International normalized ratio (INR) > 3
• Major trauma injury severity score (ISS) > 15 within the past 14 days
• Presence of intracardiac lead in the right ventricle or right atrium placed <180 days prior to the index procedure
• Cardiovascular or pulmonary surgery within last 30 days
• Actively progressing cancer requiring chemotherapy
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block
• History of severe or chronic pulmonary arterial hypertension
• History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• History of decompensated heart failure
• Patients on extracorporeal membrane oxygenation (ECMO)
• History of underlying lung disease that is oxygen dependent
• History of chest irradiation
• History of heparin-induced thrombocytopenia (HIT)
• Contraindication to systemic or therapeutic doses of heparin or anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention

Where it is running

• 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
• Medical University of Warsaw — Warsaw, Poland
• University Hospital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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