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

Purpose

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.

Condition

Pulmonary Embolism

Eligibility

Eligible Ages: Between 18 Years and 79 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Age ≥ 18 years < 80 years 2. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism. 3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery) 4. RV/LV ratio of > 0.9 on CTA as assessed by investigator (site determined). 5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids) 6. Subject or subject's legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care Protocol-specific procedures 7. Subject is willing and able to comply with all Protocol-required follow-up visits

Exclusion Criteria

Thrombolytic use within 30 days of baseline CTA 2. Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined) 3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg 4. Unstable heart rate > 130 beats per minute prior to procedure 5. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90% 6. Hematocrit < 28% 7. Platelets < 100,000/μL 8. Serum baseline creatinine > 1.8 mg/dL 9. International normalized ratio (INR) > 3 10. Major trauma injury severity score (ISS) > 15 within the past 14 days 11. Presence of intracardiac lead in the right ventricle or right atrium placed <180 days prior to the index procedure 12. Cardiovascular or pulmonary surgery within last 30 days 13. Actively progressing cancer requiring chemotherapy 14. Known bleeding diathesis or coagulation disorder 15. Left bundle branch block 16. History of severe or chronic pulmonary arterial hypertension 17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30% 18. History of decompensated heart failure 19. Patients on extracorporeal membrane oxygenation (ECMO) 20. History of underlying lung disease that is oxygen dependent 21. History of chest irradiation 22. History of heparin-induced thrombocytopenia (HIT) 23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants 24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention 26. Life expectancy of < 365 days, as determined by Investigator 27. Female who is pregnant or nursing 28. Current participation in another investigational drug or device treatment study 29. Inability to lay flat for procedure 30. Known presence of right-to-left cardiac shunt 31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days 32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Vertex Pulmonary Embolectomy System	Patients presenting with clinical signs and symptoms of acute PE and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System	Device: Vertex Pulmonary Embolectomy System Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.

Recruiting Locations

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102

Ascension Sacred Heart
Pensacola 4168228, Florida 4155751 32504

Emory University
Atlanta 4180439, Georgia 4197000 30322

Henry Ford St John
Detroit 4990729, Michigan 5001836 48236

Northwell Health
Staten Island 5139568, New York 5128638 10305

Westchester Medical Center
Valhalla 5142090, New York 5128638 10595

University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27517

Duke University
Durham 4464368, North Carolina 4482348 27705

Wake Forest Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157

UPMC
Harrisburg 5192726, Pennsylvania 6254927 17101

Penn Presbyterian
Philadelphia 4560349, Pennsylvania 6254927 19104

UPMC Presbyterian
Pittsburgh 5206379, Pennsylvania 6254927 15213

St Clair Health
Pittsburgh 5206379, Pennsylvania 6254927 15243

MUSC
Charleston 4574324, South Carolina 4597040 29425

Turkey Creek Medical Center
Knoxville 4634946, Tennessee 4662168 37934

Baylor Scott & White
Plano 4719457, Texas 4736286 75024

Carilion
Roanoke 4782167, Virginia 6254928 24014

More Details

NCT ID: NCT06576427
Status: Recruiting
Sponsor: Jupiter Endovascular

Study Contact

Karlee Hunter
7072914074
karlee@jupiterendo.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.