Actively Recruiting
Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Led by Akura Medical · Updated on 2025-07-28
30
Participants Needed
4
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 and 90 years old or younger
- Clinical signs and symptoms consistent with acute pulmonary embolism for less than 14 days
- Computed tomography angiography (CTA) evidence of proximal pulmonary embolism
- Right ventricle to left ventricle (RV/LV) ratio greater than 0.9
- Systolic blood pressure at or above 90 mmHg without the need for vasopressors
- Stable heart rate below 130 beats per minute prior to procedure
- Medically eligible for interventional procedure(s) as determined by investigator judgment
- Subject or legally authorized representative is willing and able to provide written informed consent before any protocol-specific non-standard care procedures
You will not qualify if you...
- Prior pulmonary embolism within 180 days before the procedure
- Thrombolytic use within 30 days prior to baseline computed tomography angiography
- Pulmonary hypertension with peak pulmonary artery systolic pressure over 70 mmHg by right heart catheterization
- Oxygen requirement greater than 40% fraction of inspired oxygen or over 6 liters per minute to maintain saturation above 90%
- Hematocrit less than 28%
- Platelet count below 100,000 per microliter
- Serum creatinine over 1.8 mg/dL
- International normalized ratio (INR) greater than 3
- Major trauma injury severity score over 15 before screening
- Presence of intracardiac lead placed within 6 months prior to screening
- Cardiovascular or pulmonary surgery within 7 days of procedure
- Actively progressing cancer being treated with chemotherapy
- Known bleeding or coagulation disorders
- Left bundle branch block
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with ejection fraction 30% or less
- History of decompensated heart failure
- History of oxygen-dependent lung disease
- History of chest irradiation
- History of heparin-induced thrombocytopenia
- Contraindication to systemic or therapeutic anticoagulants
- Known severe allergic reaction to radiographic contrast agents that cannot be pretreated
- Investigator judgment that participant is not appropriate for aspiration thrombectomy
- Life expectancy less than 90 days due to conditions like stage 4 cancer, frailty, or severe COVID-19
- Female who is pregnant or nursing
- Currently participating in another investigational drug or device study
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Instituto do Coracao
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
2
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-000
Actively Recruiting
3
Corazones Del Cibao
Santiago de los Caballeros, Santiago Province, Dominican Republic, 51000
Not Yet Recruiting
4
Centro de Intervenciones Cardiovasculares
Santiago de los Caballeros, Santiago Province, Dominican Republic
Actively Recruiting
Research Team
R
Rukhsana Khanum
CONTACT
U
Uday Illindala
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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