Evaluating the Akura Thrombectomy System for treating acute pulmonary embolism

Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism

This study is testing a new device called the Akura Thrombectomy System to see if it can safely and effectively treat people with acute pulmonary embolism.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Akura Medical (Industry-sponsored)
• Locations: 1 site (Graz)
• Trial ID: NCT06362928 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Akura Thrombectomy System for patients suffering from acute pulmonary embolism. It is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study. Participants will undergo percutaneous mechanical thrombectomy to assess the device's performance in treating this condition. The study aims to gather data on patient outcomes and the procedure's safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with clinical signs of acute pulmonary embolism and specific imaging findings.

Not a fit: Patients with a history of pulmonary embolism within the last 180 days or those who have received thrombolytic therapy within 48 hours prior to the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with acute pulmonary embolism.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies using mechanical thrombectomy for pulmonary embolism have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Patient is \> 18 and \< 90 years old
2. Clinical signs and symptoms consistent with acute PE
3. PE symptom duration ≤ 14 days
4. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator)
5. CTA evidence of RV/LV ratio \> 0.9 note: based on Investigator's interpretation of RV/LV ratio at baseline;
6. Systolic BP ≥ 90 mmHg note: initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation
7. Stable heart rate (HR) \< 130 BPM prior to procedure
8. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment.
9. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures

Exclusion Criteria:

1. Prior PE \< 180 days from index procedure
2. Thrombolytic use \< 48 hours prior to baseline CTA
3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
4. Vasopressor requirement after fluids to keep pressure at ≥90 mmHg
5. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
6. Hematocrit \<28% (Note: hematocrit required within 6 hrs. of index procedure)
7. Platelets count \<100,000/µL
8. eGFR \<30 ml/min per 1.73 m2
9. International normalized ratio (INR) \>3
10. Major trauma injury severity score (ISS) \> 15
11. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
12. Cardiovascular or pulmonary surgery within 7 days of index procedure
13. Actively progressing cancer treated by chemotherapeutics
14. Known bleeding diathesis or coagulation disorder
15. Left bundle branch block
16. History of severe or chronic pulmonary arterial hypertension
17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
18. History of decompensated heart failure
19. History of underlying lung disease that is oxygen dependent
20. History of chest irradiation
21. History of heparin-induced thrombocytopenia (HIT)
22. Contraindication to systemic or therapeutic doses of anticoagulants
23. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
24. Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle).
25. CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus)
26. Life expectancy \<90 days, as determined by investigator
27. Female who is pregnant or nursing
28. Current participation in another investigational drug or device treatment study Note: observational or registry studies may be permitted with Sponsor approval

Where this trial is running

Graz

• Univ.-Klinikum LKH Graz — Graz, Austria (Recruiting)

Study contacts

• Study coordinator: Rukhsana Khanum

Conditions Pulmonary Embolism Acute