Pulmonary EmbolismSPIRARE IINCT06576427
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
A study testing Vertex Pulmonary Embolectomy System in people with Pulmonary Embolism, run by Jupiter Endovascular at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Vertex Pulmonary Embolectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 15 Oct 2024to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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
Who cannot join
- 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%
Show all 32Show fewer
- 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
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- History of decompensated heart failure
- Patients on extracorporeal membrane oxygenation (ECMO)
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic doses of heparin or anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention
- Life expectancy of < 365 days, as determined by Investigator
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
- Inability to lay flat for procedure
- Known presence of right-to-left cardiac shunt
- History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
- Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States18 sites
Emory University
Atlanta, Georgia, 30322
University of North Carolina
Chapel Hill, North Carolina, 27517
MUSC
Charleston, South Carolina, 29425
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford St John
Detroit, Michigan, 48236
Duke University
Durham, North Carolina, 27705
Hartford Hospital
Hartford, Connecticut, 06102
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
NYU Langone Health
New York, New York, 10016
Ascension Sacred Heart
Pensacola, Florida, 32504
Penn Presbyterian
Philadelphia, Pennsylvania, 19104
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
St Clair Health
Pittsburgh, Pennsylvania, 15243
Baylor Scott & White
Plano, Texas, 75024
Carilion
Roanoke, Virginia, 24014
Northwell Health
Staten Island, New York, 10305
Westchester Medical Center
Valhalla, New York, 10595
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157
Poland3 sites
St. John Paul II Hospital
Krakow
European Health Center Otwock
Otwock, 05-400
Medical University of Warsaw
Warsaw
About this study
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.
Read the 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
- Being tested
- Vertex Pulmonary Embolectomy System
- Keywords
- Embolism and Thrombosis, Pulmonary Embolism, Embolism, Cardiovascular Diseases
- Medical subject headings
- Pulmonary Embolism, Embolism and Thrombosis, Embolism, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertex Pulmonary Embolectomy SystemDevice
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Vertex Pulmonary Embolectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Within 48 hours of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start15 Oct 2024
- Primary completion4 Feb 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jupiter Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aadi Chachad, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576427
- Sponsor's protocol ID
- CSP-02
- Acronym
- SPIRARE II
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sayfo S, Stepniewski J, Gallo V, Rossi JS, Lang IM, Ingrassia J, Rosenberg RD, Amin R, Aggarwal V, Jaber W, Mahfoud F, Kopec G, Toma C, Ii Trial Investigators OBOTS. Safety and effectiveness of the Vertex Pulmonary Embolectomy System in acute intermediate-risk pulmonary embolism: the SPIRARE II pivotal trial. EuroIntervention. 2026 Oct 19;22(20):e1115-e1126. doi: 10.4244/EIJ-D-26-00454.
PubMed 42910977
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
- ClinicalTrials.gov ID
- NCT06576427
- Acronym / sponsor ID
- SPIRARE II / CSP-02
- Conditions
- Pulmonary Embolism
- Keywords
- Embolism and Thrombosis, Pulmonary Embolism, Embolism, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Jupiter EndovascularIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vertex Pulmonary Embolectomy System | Experimental | Device: Vertex Pulmonary Embolectomy SystemPatients presenting with clinical signs and symptoms of acute PE and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- . 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)
Key exclusion criteria (32 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertex Pulmonary Embolectomy SystemUse of Vertex Pulmonary Embolectomy System to treat pulmonary embolism. | Device | Vertex Pulmonary Embolectomy System |
Primary outcome
Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio
Time frame: From baseline to 48 hours or discharge
Reduction in RV/LV ratio from baseline to 48 hours or discharge by (core lab assessed) CT angiography
Major Adverse Events, a composite of:
Time frame: Within 48 hours of the procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 42910977Sayfo S, Stepniewski J, Gallo V, Rossi JS, Lang IM, Ingrassia J, Rosenberg RD, Amin R, Aggarwal V, Jaber W, Mahfoud F, Kopec G, Toma C, Ii Trial Investigators OBOTS. Safety and effectiveness of the Vertex Pulmonary Embolectomy System in acute intermediate-risk pulmonary embolism: the SPIRARE II pivotal trial. EuroIntervention. 2026 Oct 19;22(20):e1115-e1126. doi: 10.4244/EIJ-D-26-00454.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aadi Chachad study director
Sponsor GmbH
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertex Pulmonary Embolectomy System in people with Pulmonary Embolism, run by Jupiter Endovascular at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Poland, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio (time frame: From baseline to 48 hours or discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.