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

NCT06571760 | Completed Results FDA Device

• 1 other identifier: CSP-01
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pulmonary Embolism

Keywords

Embolism and Thrombosis; Pulmonary Embolism; Embolism; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Vertex Pulmonary Embolectomy System

EXPERIMENTAL

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

Interventions

Vertex Pulmonary Embolectomy System DEVICE

Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.

Vertex Pulmonary Embolectomy System

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years \< 80 years
• Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
• CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined).
• Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• Subject is willing and able to provide written informed consent prior to receiving any non-standard of care clinical investigation plan specific procedures
• Subject is willing and able to comply with all clinical investigation plan required follow-up visits

You may not qualify if:

• Thrombolytic use within 30 days of baseline CTA
• Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined)
• Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
• Unstable heart rate \> 130 beats per minute prior to procedure
• FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
• Hematocrit \< 28%
• Platelets \< 100,000/µL
• Serum baseline creatinine \> 1.8 mg/dL
• International normalized ratio (INR) \> 3
• Major trauma injury severity score (ISS) \> 15 within the past 14 days
• Presence of intracardiac lead in the right ventricle or right atrium placed \<180 days prior to the index procedure
• Cardiovascular or pulmonary surgery within last 30 days
• Actively progressing cancer requiring chemotherapy
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block

Sponsors & Collaborators

• Neptune Medical: lead

Study Sites (2)

AKH Vienna - Medical university of Vienna

Vienna, 1090, Austria

Location

Jagiellonian University

Krakow, Poland

Location

MeSH Terms

Conditions

Pulmonary Embolism; Embolism and Thrombosis; Embolism; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Vascular Diseases

Results Point of Contact

• Title: Karlee Doolittle
• Organization: Jupiter Endovascular

karlee@jupiterendo.com

707-291-4074

Study Officials

• Aadi Chachad

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: September 10, 2024
• Primary Completion: April 24, 2025
• Study Completion: May 21, 2025
• Last Updated: May 19, 2026
• Results First Posted: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); AU (1)