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

NCT ID: NCT06362928

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-02-28

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).

Conditions

Pulmonary Embolism Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Acute Pulmonary Embolism

Patients undergoing mechanical thrombectomy for acute pulmonary embolism.

Group Type: EXPERIMENTAL

ATC System

Intervention Type: DEVICE

The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE

Interventions

ATC System

The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akura Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univ.-Klinikum LKH Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Rukhsana Khanum

Role: CONTACT

clinicalaffairs@akuramed.com

4085602500

Uday Illindala

Role: CONTACT

clinicalaffairs@akuramed.com

4085602500

Facility Contacts

Claudia Wöhrer,

Role: primary

claudia.woehrer@medunigraz.at

Other Identifiers

CP-60005

Identifier Type: -

Identifier Source: org_study_id