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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Vertex Pulmonary Embolectomy System

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • AKH Vienna - Medical university of Vienna
• Poland
  • Krakow, Poland
    • Jagiellonian University

Participation Criteria

Eligibility Criteria

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

Description

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

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: 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	Device: Vertex Pulmonary Embolectomy System; Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Right Ventricle/Left Ventricle (RV/LV) Ratio	The RV/LV diameter ratio is defined as the ratio of the maximal right ventricle (RV) to left ventricle (LV) diameters measured on computed tomography (CT) pulmonary angiography images. Measurements are performed by an independent core laboratory using standardized axial CT images, with ventricular diameters measured at the widest point of each ventricle. Change in RV/LV ratio is calculated for each participant as the difference between the value obtained at baseline (pre-procedure) and the value obtained at 48 hours post-procedure or at hospital discharge, whichever occurs first. A reduction in RV/LV ratio indicates improvement in right ventricular dilatation.	From baseline to 48 hours or discharge
Major Adverse Events (MAEs)	A composite of: Device-related death within 48 hours Major bleeding within 48 hours Device-related AEs within 48 hours, including: Clinical deterioration; Pulmonary vascular injury; Cardiac injury	Within 48 hours of procedure

Collaborators and Investigators

• Sponsor: Neptune Medical
• Investigators: Study Director: Aadi Chachad, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Embolism; Pulmonary Embolism; Embolism and Thrombosis
• Additional Relevant MeSH Terms: Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Cardiovascular Diseases; Pulmonary Embolism; Embolism; Embolism and Thrombosis
• Other Study ID Numbers: CSP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will not be sharing IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes