Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
- Conditions
- Pulmonary Embolism
- Registration Number
- NCT06576427
- Lead Sponsor
- Jupiter Endovascular
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio From baseline to 48 hours or discharge Reduction in RV/LV ratio from baseline to 48 hours or discharge by (core lab assessed) CT angiography
Major Adverse Events, a composite of: Within 48 hours of the procedure Device-related death within 48 hours of the procedure Major bleeding within 48 hours of the procedure
Device-related AEs within 48 hours, including:
* Clinical deterioration
* Pulmonary vascular injury
* Cardiac injury
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Henry Ford St John
🇺🇸Detroit, Michigan, United States
Northwell Health
🇺🇸Staten Island, 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
UPMC
🇺🇸Harrisburg, Pennsylvania, United States
Scroll for more (9 remaining)Westchester Medical Center🇺🇸Valhalla, New York, United States