Actively Recruiting
Safety and Effectiveness of the Akura Thrombectomy System for Removing Emboli in Acute Pulmonary Embolism
Led by Akura Medical · Updated on 2025-12-17
118
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Akura Thrombectomy System in treating patients with acute pulmonary embolism (PE). This interventional, multicenter study focuses on using the device to mechanically remove emboli from the pulmonary arteries. The goal is to assess how well the system restores blood flow and to monitor any major adverse device-related events within 48 hours after treatment. Participants receive treatment with the Akura Thrombectomy System, designed to mechanically clear emboli and improve blood flow in the lungs. This study involves patients undergoing mechanical thrombectomy specifically for acute PE. There is one study group that includes all patients receiving this device-based procedure. During the trial, participants will be closely observed for safety and effectiveness outcomes, including major adverse events up to 30 days after the procedure. The primary measures focus on device-related safety and performance within 48 hours. Participants will be monitored through clinical assessments and imaging to evaluate the procedure's impact and safety. The study is expected to continue until December 2026.
CONDITIONS
Brief 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 the procedure
- Signs and symptoms consistent with acute pulmonary embolism
- Symptom duration of 14 days or less
- CTA shows proximal pulmonary embolism in at least one main or lobar artery
- CTA shows right to left ventricular ratio of 0.9 or higher
- Systolic blood pressure at least 90 mmHg (or recovers to at least 80 mmHg with fluids)
- Stable heart rate less than 130 beats per minute before the procedure
You will not qualify if you...
- Prior pulmonary embolism within 180 days before the procedure
- Thrombolytic therapy within 30 days before baseline CTA
- Pulmonary hypertension with peak arterial pressure over 70 mmHg
- Need for vasopressors after fluids to maintain blood pressure at or above 90 mmHg
- Oxygen requirement over 40% FiO2 or more than 6 liters per minute
- Hematocrit below 28% within 6 hours before procedure
- Platelet count below 100,000 per microliter
- Kidney function (eGFR) below 30 ml/min per 1.73 m2
- International normalized ratio (INR) greater than 3
- Major trauma injury severity score above 15
- Presence of intracardiac lead placed within 6 months
- Cardiovascular or lung surgery within last 7 days
- Active progressing cancer treated with chemotherapy
- Known bleeding or clotting disorders
- Left bundle branch block
- Severe or chronic pulmonary arterial hypertension
- Chronic left heart disease with ejection fraction 30% or less
- Uncompensated heart failure
- Oxygen-dependent lung disease
- History of chest radiation
- History of heparin-induced thrombocytopenia
- Contraindication to anticoagulants
- Severe allergic reaction to radiographic contrast agents without pretreatment
- Known residual iliac deep vein thrombosis or clot in heart chambers
- Imaging shows subject not suitable for mechanical thrombectomy
- Life expectancy less than 90 days
- Pregnant or nursing females
- Current participation in another investigational drug or device study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo mechanical thrombectomy using the Akura Thrombectomy System to remove emboli from the pulmonary arteries.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for safety and effectiveness outcomes following the thrombectomy procedure.
Approximately 2 follow-up visits (in-person)
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
U
Uday Illindala
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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