Focused Lung Treatment to Reduce Right Heart Strain
Zusammenfassung der Studie
Pulmonary embolism (PE) is a blood clot that blocks and stops blood flow to an artery in the lung. Patients with PE may experience shortness of breath, chest pain, and/or an irregular heartbeat. The symptoms arise due to abnormal heart function. PE can be fatal, but prompt treatment significantly reduces the risk of death. With this clinical study, we hope to gather data on the safety and efficacy of the Vertex Pulmonary Embolectomy System in patients with acute PE. Up to 145 patients will be enrolled in the study. All participating patients will receive treatment with the investigational product. The Vertex Pulmonary Embolectomy System is a medical device intended for use in the pulmonary arteries for: • The non-surgical removal of blood clots from blood vessels. • The injection, infusion, and/or aspiration of contrast agents and other fluids into or out of a blood vessel. The general procedures in this study include inserting a catheter into a large vein in the leg to bring the medical device into the arteries of the lung that contain the blood clots, removing the clots, administering blood-thinning medications, imaging of the heart and lungs, blood tests, and other routine blood tests. The total study duration is approximately 30 days and includes the initial screening examination, hospitalization with the procedure performed, discharge from the hospital, and a follow-up visit 30 days after the procedure.
(BASEC)
Untersuchte Intervention
Patients with clinical signs and symptoms of blood clots in the lung and heart who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System. In this study, we will investigate the safety and efficacy of the Vertex Pulmonary Embolectomy System in patients who exhibit clinical signs and symptoms of blood clots in the lung that have formed suddenly within the last 14 days. Up to one hundred twenty-three (123) evaluable subjects will be treated in this study.
(BASEC)
Untersuchte Krankheit(en)
Acute Pulmonary Embolism Investigating the safety and efficacy of the new medical device Vertex Pulmonary Embolectomy System for the mechanical aspiration of clots in the treatment of acute pulmonary embolism (PE).
(BASEC)
1. Acute onset of symptoms < 14 days indicating pulmonary embolism. 2. RV/LV ratio of > 0.9 on CTA as assessed by the investigator (determined by the study center). 3. Systolic blood pressure ≥ 90 mmHg (the initial systolic blood pressure may be ≥ 80 mmHg if the pressure recovers with fluids to ≥ 90 mmHg) (BASEC)
Ausschlusskriterien
1. Use of thrombolytics within 30 days of baseline CT angiography (CTA) 2. Pulmonary hypertension with peak pressure in the pulmonary artery > 70 mmHg by right heart catheterization (determined by the study center) 3. Vasopressor required after fluids to maintain pressure at ≥ 90 mmHg (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
The Sponsor: Neptune Medical Inc. The Sponsor's Representative: Effectum Medical AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Karlee Hunter
+1 7072914074
karlee@clutterneptunemedical.comNeptune Medical Inc.
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.05.2025
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II. The SPIRARE II Study (BASEC)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar