Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I

NCT ID: NCT06571760

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-05-21

Brief Summary

This study study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of pulmonary embolism.

Detailed Description

The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.

The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.

Conditions

Pulmonary Embolism

Study Design

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

Study Groups

Vertex Pulmonary Embolectomy System

Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System

Group Type: EXPERIMENTAL

Vertex Pulmonary Embolectomy System

Intervention Type: DEVICE

Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.

Interventions

Vertex Pulmonary Embolectomy System

Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years < 80 years

2. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.

3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)

4. RV/LV ratio of > 0.9 on CTA as assessed by investigator (site determined).

5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)

6. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care clinical investigation plan specific procedures

7. Subject is willing and able to comply with all clinical investigation plan required follow-up visits

Exclusion Criteria

1. Thrombolytic use within 30 days of baseline CTA

2. Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)

3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg

4. Unstable heart rate > 130 beats per minute prior to procedure

5. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%

6. Hematocrit < 28%

7. Platelets < 100,000/µL

8. Serum baseline creatinine > 1.8 mg/dL

9. International normalized ratio (INR) > 3

10. Major trauma injury severity score (ISS) > 15 within the past 14 days

11. Presence of intracardiac lead in the right ventricle or right atrium placed <180 days prior to the index procedure

12. Cardiovascular or pulmonary surgery within last 30 days

13. Actively progressing cancer requiring chemotherapy

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. Patients on extracorporeal membrane oxygenation (ECMO)

20. History of underlying lung disease that is oxygen dependent

21. History of chest irradiation

22. History of heparin-induced thrombocytopenia (HIT)

23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants

24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated

25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention

26. Life expectancy of < 365 days, as determined by Investigator

27. Female who is pregnant or nursing

28. Current participation in another investigational drug or device treatment study

29. Inability to lay flat for procedure

30. Known presence of right-to-left cardiac shunt

31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days

32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neptune Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aadi Chachad

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

AKH Vienna - Medical university of Vienna

Vienna, , Austria

Jagiellonian University

Krakow, , Poland

Countries

Austria; Poland

Other Identifiers

CSP-01

Identifier Type: -

Identifier Source: org_study_id