Status:
COMPLETED
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
Lead Sponsor:
Neptune Medical
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
This study 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 ...
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 symptom...
Eligibility Criteria
Inclusion
- 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 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
Exclusion
- 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
- Life expectancy of \< 365 days, as determined by Investigator
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
- Inability to lay flat for procedure
- Known presence of right-to-left cardiac shunt
- History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
- Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06571760
Start Date
September 10 2024
End Date
May 21 2025
Last Update
May 29 2025
Active Locations (2)
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1
AKH Vienna - Medical university of Vienna
Vienna, Austria, 1090
2
Jagiellonian University
Krakow, Poland