Focused Lung Treatment to Reduce Right Heart Strain
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
The Sponsor: Neptune Medical Inc. The Sponsor's Representative: Effectum Medical AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Karlee Hunter
+1 7072914074
karlee@clutterneptunemedical.comNeptune Medical Inc.
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
20.05.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II. The SPIRARE II Study (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile