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)

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).

Study Overview

• Status: Suspended
• Conditions: Pulmonary Embolism Acute
• Intervention / Treatment: Device: ATC

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Healthcare
  • Florida
    • Bradenton, Florida, United States, 32408
      • Manatee Memorial Hospital / Nova Clinical Research Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • New York
    • New York, New York, United States, 10032
      • Cumc/Nyph
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient is 18 years of age or older and deemed medically eligible for interventional 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

Exclusion Criteria:

• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Acute Pulmonary Embolism; Patients undergoing mechanical thrombectomy for acute pulmonary embolism.	Device: ATC; The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Composite of Major Adverse Device-Related Events	Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury	48 hours post index procedure
Effectiveness	Change in RV/LV ratio from baseline	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Composite of Major Adverse Events	Assessment of major adverse events through 30 day follow-up	30 days post index procedure

Collaborators and Investigators

• Sponsor: Akura Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: CP-60006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes