Actively Recruiting
Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
Led by Akura Medical · Updated on 2025-12-17
118
Participants Needed
12
Research Sites
99 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 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 for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older and medically eligible for an interventional procedure
- Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism
- Pulmonary embolism symptom duration of 14 days or less
- CTA showing proximal pulmonary embolism in at least one main or lobar pulmonary artery
- CTA showing right ventricle to left ventricle (RV/LV) ratio of 0.9 or higher
- Systolic blood pressure of 90 mmHg or higher (or at least 80 mmHg if it improves with fluids)
- Stable heart rate below 130 beats per minute before the procedure
You will not qualify if you...
- Prior pulmonary embolism within 180 days before the procedure
- Use of thrombolytic therapy within 30 days before baseline CTA
- Pulmonary hypertension with peak pulmonary arterial pressure over 70 mmHg
- Need for vasopressors after fluids to keep blood pressure at 90 mmHg or higher
- Oxygen requirement above 40% FiO2 or more than 6 L per minute to keep saturation above 90%
- Hematocrit below 28% within 6 hours before procedure
- Platelet count below 100,000 per microliter
- Estimated glomerular filtration rate below 30 ml/min per 1.73 m2
- International normalized ratio (INR) above 3
- Major trauma injury severity score above 15
- Presence of intracardiac lead in right ventricle or atrium placed 6 months or less before enrollment
- Cardiovascular or pulmonary surgery within the last 7 days
- Actively progressing cancer treated with chemotherapy
- Known bleeding or clotting 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% or less
- History of uncompensated heart failure
- History of lung disease requiring oxygen
- History of chest radiation therapy
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic anticoagulants
- Known severe allergic reaction to contrast agents that cannot be treated beforehand
- Known residual deep vein thrombosis, inferior vena cava clot, or clot in transit in heart chambers
- Imaging or other evidence suggesting patient is not suitable for mechanical thrombectomy
- Life expectancy less than 90 days due to serious conditions
- 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: 12 locations
1
Los Robles Regional Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
2
Advanced Heart & Vein (ClinRe-001-001)
Thornton, Colorado, United States, 80023
Actively Recruiting
3
Hartford Healthcare
Hartford, Connecticut, United States, 06102
Actively Recruiting
4
Manatee Hospital / Nova Clinical Research Center
Bradenton, Florida, United States, 32808
Active, Not Recruiting
5
Jacksonville Memorial (HCA)
Jacksonville, Florida, United States, 32216
Active, Not Recruiting
6
Tallahasse Memorial Hospital
Tallahassee, Florida, United States, 32308
Actively Recruiting
7
Centracare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56301
Actively Recruiting
8
Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
9
Cumc/Nyph
New York, New York, United States, 10032
Not Yet Recruiting
10
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
11
Tristar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Methodist San Antonio (HCA)
San Antonio, Texas, United States, 78229
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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