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Tests treatment safety and results for Pulmonary Embolism Acute
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)
ClinicalTrials.gov ID: NCT06672510
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient is 18 years of age or older and deemed medically eligible for treatment procedure, per institutional guidelines and clinical judgement
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at...
You likely can't join if
- Prior PE \<180 days from index procedure
- Thrombolytic use within 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
- FiO2 requirement \> 40% or \> 6 LPM (to keep oxygen saturation \> 90%)
- Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure)
See the full eligibility criteria
- The patient is 18 years of age or older and deemed medically eligible for treatment procedure, per institutional guidelines and clinical judgement
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
- Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
- Stable HR \< 130 BPM prior to the procedure
- Prior PE \<180 days from index procedure
- Thrombolytic use within 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
- FiO2 requirement \> 40% or \> 6 LPM (to keep oxygen saturation \> 90%)
- Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure)
- Platelets \< 100,000/μL
- eGFR \<30 ml/min per 1.73 m2
- International normalized ratio (INR) \> 3
- Major trauma injury severity score (ISS) \> 15
- Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
- Cardiovascular or pulmonary surgery within the last 7 days
- Actively progressing cancer treated by chemotherapeutics
- Known bleeding diathesis or coagulation 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%
- History of uncompensated heart failure.
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic doses of anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
- CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly...
- Life expectancy \< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Thousand Oaks, California, United States
- Thornton, Colorado, United States
- Hartford, Connecticut, United States
- Bradenton, Florida, United States
- Jacksonville, Florida, United States
- Tallahassee, Florida, United States
- Saint Cloud, Minnesota, United States
- New York, New York, United States
- Toledo, Ohio, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thousand Oaks, California, United States; Thornton, Colorado, United States; Hartford, Connecticut, United States; Bradenton, Florida, United States; Jacksonville, Florida, United States; Tallahassee, Florida, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.