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

NCT06576427 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CSP-02
• Study Type: interventional
• Target: 123
• Locations: 4 countries
• Sites: 23

Brief Summary

This 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.

Conditions

Pulmonary Embolism

Keywords

Embolism and Thrombosis; Pulmonary Embolism; Embolism; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio

  Reduction in RV/LV ratio from baseline to 48 hours or discharge by (core lab assessed) CT angiography

  From baseline to 48 hours or discharge

• Major Adverse Events, a composite of:

  Device-related death within 48 hours of the procedure Major bleeding within 48 hours of the procedure Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury

  Within 48 hours of the procedure

Study Arms (1)

Vertex Pulmonary Embolectomy System

EXPERIMENTAL

Patients presenting with clinical signs and symptoms of acute PE 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 or subject's legally authorized representative (LAR) - applicable for US 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

• Jupiter Endovascular: lead

Study Sites (23)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford St John

Detroit, Michigan, 48236, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Northwell Health

Staten Island, New York, 10305, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

St Clair Health

Pittsburgh, Pennsylvania, 15243, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Baylor Scott & White

Plano, Texas, 75024, United States

Location

Carilion

Roanoke, Virginia, 24014, United States

Location

Medical University of Vienna

Vienna, Austria

Location

St. John Paul II Hospital

Krakow, Poland

Location

European Health Center Otwock

Otwock, 05-400, Poland

Location

Medical University of Warsaw

Warsaw, Poland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Embolism; Embolism and Thrombosis; Embolism; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Vascular Diseases

Study Officials

• Aadi Chachad

  Sponsor GmbH

  STUDY DIRECTOR

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: April 18, 2024
• First Posted: August 28, 2024
• Study Start: October 15, 2024
• Primary Completion: February 4, 2026
• Study Completion: March 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); CH (1); AU (1); PL (3)