Pulmonary EmbolismSPIRARE INCT06571760
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
A study testing Vertex Pulmonary Embolectomy System in people with Pulmonary Embolism, run by Neptune Medical at 2 sites in 2 countries.
Trial 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. 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
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Sep 2024to 21 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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 pulmonary embolism 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.
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.
Measured: 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
Measured: Within 48 hours of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start10 Sep 2024
- Primary completion24 Apr 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neptune Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aadi Chachad, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571760
- Sponsor's protocol ID
- CSP-01
- Acronym
- SPIRARE I
- Status last verified
- May 2026
- First submitted
- 23 Aug 2024
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Will not be sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 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-I
- ClinicalTrials.gov ID
- NCT06571760
- Acronym / sponsor ID
- SPIRARE I / CSP-01
- Conditions
- Pulmonary Embolism
- Keywords
- Embolism and Thrombosis, Pulmonary Embolism, Embolism, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Neptune MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 pulmonary embolism 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
Change in Right Ventricle/Left Ventricle (RV/LV) Ratio
Time frame: From baseline to 48 hours or discharge
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.
Major Adverse Events (MAEs)
Time frame: Within 48 hours of procedure
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Will not be sharing IPD.
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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
2 sites in 2 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 Neptune Medical at 2 sites in 2 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Poland. 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?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Right Ventricle/Left Ventricle (RV/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?
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 19 May 2026.