Actively Recruiting
Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
Led by Akura Medical · Updated on 2025-07-28
15
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
CONDITIONS
Official Title
Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is over 18 and under 90 years old
- Clinical signs and symptoms consistent with acute pulmonary embolism
- Pulmonary embolism symptom duration is 14 days or less
- Imaging shows proximal pulmonary embolism in at least one main or lobar pulmonary artery
- Imaging shows right ventricle to left ventricle ratio greater than 0.9
- Systolic blood pressure is at least 90 mmHg or at least 80 mmHg if it recovers with fluid treatment
- Stable heart rate less than 130 beats per minute before the procedure
- Medically eligible for interventional procedure(s) as determined by the investigator
- Subject or legally authorized representative is willing and able to provide written informed consent prior to any protocol-specific procedures
You will not qualify if you...
- Prior pulmonary embolism less than 180 days before the procedure
- Use of thrombolytic drugs less than 48 hours before baseline imaging
- Pulmonary hypertension with peak pulmonary artery systolic pressure over 70 mmHg
- Need for vasopressors after fluids to keep blood pressure at or above 90 mmHg
- Need for oxygen with FiO2 over 40% or more than 6 liters per minute to keep oxygen saturation above 90%
- Hematocrit less than 28% within 6 hours of the procedure
- Platelet count less than 100,000 per microliter
- Estimated glomerular filtration rate less than 30 ml/min per 1.73 m2
- International normalized ratio over 3
- Major trauma injury severity score over 15
- Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening
- Cardiovascular or pulmonary surgery within 7 days before the procedure
- Actively progressing cancer treated by 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 contrast agents that cannot be pretreated
- Known residual iliac deep vein thrombosis, inferior vena cava clot, or clot in transit
- Imaging or investigator opinion indicates subject is not suitable for aspiration thrombectomy
- Life expectancy less than 90 days
- Female who is pregnant or nursing
- Current participation in another investigational drug or device study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Univ.-Klinikum LKH Graz
Graz, Austria
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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