Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Not Applicable
Recruiting
- Conditions
- Pulmonary Embolism Acute
- Interventions
- Device: ATC System
- Registration Number
- NCT06152341
- Lead Sponsor
- Akura Medical
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with Acute Pulmonary Embolism ATC System Patients undergoing mechanical thrombectomy for acute pulmonary embolism.
- Primary Outcome Measures
Name Time Method Effectiveness 48 hours post index procedure Change in RV/LV ratio
Safety: Composite of Major Adverse Device-Related Events 48 hours post index procedure Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
- Secondary Outcome Measures
Name Time Method Safety: Composite of Major Adverse Events 30 days post index procedure Assessment of major adverse events through 30 day follow-up
Trial Locations
- Locations (4)
Centro de Intervenciones Cardiovasculares
🇩🇴Santiago De Los Caballeros, Santiago, Dominican Republic
Instituto do Coracao
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷Sao Paulo, Brazil
Corazones Del Cibao
🇩🇴Santiago De Los Caballeros, Santiago, Dominican Republic