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Mechanical Thrombectomy Device
Akura Thrombectomy System for Pulmonary Embolism
Nashville, TN
N/A
Recruiting
Research Sponsored by Akura Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical signs, symptoms and presentation consistent with acute PE
PE symptom duration ≤ 14 days
Must not have
Pulmonary hypertension with peak pulmonary arterial pressure (PAP) > 70 mmHg by right heart catheterization
History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at how safe and effective a new method called percutaneous mechanical thrombectomy is for treating acute pulmonary embolism.
See full description
Who is the study for?
This trial is for adults over 18 with acute pulmonary embolism (PE), showing symptoms for less than two weeks. They must have a CT scan showing a blockage in the main lung arteries and an enlarged right side of the heart compared to the left. Their blood pressure and heart rate must be within certain limits.Check my eligibility
What is being tested?
The study tests the Akura Thrombectomy System, a device designed to mechanically remove clots from lung arteries in patients with acute PE. It's an observational study where all participants receive this intervention without comparison to another treatment.See study design
What are the potential side effects?
While specific side effects are not listed, procedures like thrombectomy can cause bleeding, infection at the entry site, damage to blood vessels, irregular heartbeat or reactions related to sedation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am showing signs of a pulmonary embolism.
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My symptoms of pulmonary embolism have been present for 2 weeks or less.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart's pulmonary pressure is above 70 mmHg.
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My heart's pumping ability is significantly reduced.
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I cannot take blood thinners.
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I need medication to maintain my blood pressure above 90 mmHg.
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My kidney function is severely reduced.
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I have a bleeding or clotting disorder.
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I need extra oxygen to maintain my oxygen levels above 90%.
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I have not had heart or lung surgery in the past week.
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My cancer is getting worse despite chemotherapy.
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I have a history of severe lung blood pressure issues.
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I need oxygen because of a lung condition.
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I have had radiation therapy to my chest in the past.
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I am currently pregnant or nursing.
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I have had heart failure that was not successfully treated.
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I have a known clot in my leg, IVC, or heart.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effectiveness
Safety: Composite of Major Adverse Device-Related Events
Secondary study objectives
Safety: Composite of Major Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with Acute Pulmonary EmbolismExperimental Treatment1 Intervention
Patients undergoing mechanical thrombectomy for acute pulmonary embolism.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATC
2004
N/A
~50
Find a Location
Closest Location:Tristar Centennial Medical Center· Nashville, TN· 334 miles
Who is running the clinical trial?
Akura MedicalLead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
2 Trials studying Pulmonary Embolism
45 Patients Enrolled for Pulmonary Embolism