Clinical trial NCT06362928: Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
Official title: Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism Acute
Lead sponsor: Akura Medical
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).


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

Primary outcomes:
measure: Effectiveness
timeFrame: 48 hours
measure: Safety: Composite of Major Adverse Device-Related Events
timeFrame: 48 hours post index procedure
Secondary outcomes:
measure: Safety: Composite of Major Adverse Events
timeFrame: 30 days post index procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Univ.-Klinikum LKH Graz
Study officials:
References: