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)
NCT ID: NCT06672510
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
118 participants
INTERVENTIONAL
2025-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with Acute Pulmonary Embolism
Patients undergoing mechanical thrombectomy for acute pulmonary embolism.
ATC
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute P
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATC
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute P
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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 chronic clot or non-clot embolus)
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akura Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Robles Regional Medical Center
Thousand Oaks, California, United States
Advanced Heart & Vein (ClinRe-001-001)
Thornton, Colorado, United States
Hartford Healthcare
Hartford, Connecticut, United States
Manatee Hospital / Nova Clinical Research Center
Bradenton, Florida, United States
Jacksonville Memorial (HCA)
Jacksonville, Florida, United States
Tallahasse Memorial Hospital
Tallahassee, Florida, United States
Centracare Heart & Vascular Center
Saint Cloud, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Cumc/Nyph
New York, New York, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Tristar Centennial Medical Center
Nashville, Tennessee, United States
Methodist San Antonio (HCA)
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Vuppalapu Vidhath
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP-60006
Identifier Type: -
Identifier Source: org_study_id