Status:
RECRUITING
Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Lead Sponsor:
Akura Medical
Conditions:
Pulmonary Embolism Acute
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).
Eligibility Criteria
Inclusion
- Patient is ≥ 18 and ≤ 90 years old
- Clinical signs and symptoms consistent with acute PE for \< 14 days
- CTA evidence of proximal PE
- RV/LV ratio \> 0.9
- Systolic BP ≥90 mmHg without the need for vasopressors
- Stable heart rate (HR) \< 130 BPM prior to procedure
- Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
- Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
Exclusion
- Prior PE \< 180 days from index procedure
- Thrombolytic use \< 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
- FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
- Hematocrit \<28%
- Platelets count \<100,000/µL
- Serum creatinine \>1.8 mg/dL
- International normalized ratio (INR) \>3
- Major trauma injury severity score (ISS) \>15 prior to screening assessment
- Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
- Cardiovascular or pulmonary surgery within 7 days of index procedure
- Actively progressing cancer treated by chemotherapeutics
- 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
- 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 anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
- Life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study.
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06152341
Start Date
May 15 2024
End Date
September 15 2025
Last Update
July 28 2025
Active Locations (4)
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1
Instituto do Coracao
São Paulo, São Paulo, Brazil, 05403-000
2
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-000
3
Corazones Del Cibao
Santiago de los Caballeros, Santiago Province, Dominican Republic, 51000
4
Centro de Intervenciones Cardiovasculares
Santiago de los Caballeros, Santiago Province, Dominican Republic