Pulmonary Embolism AcuteNCT06672510
Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
A study testing ATC in people with Pulmonary Embolism Acute, run by Akura Medical at 7 sites in United States.
Trial summary
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- ATC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Jan 2025to Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
- Systolic BP ≥ 90 mmHg (initial SBP may be < 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
- Stable HR < 130 BPM prior to the procedure
Who cannot join
- Prior PE <180 days from index procedure
- Thrombolytic use within 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary arterial pressure (PAP) > 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
- FiO2 requirement > 40% or > 6 LPM (to keep oxygen saturation > 90%)
- Hematocrit < 28% (Note: hematocrit required within 6 hrs. of index procedure)
Show all 28Show fewer
- Platelets < 100,000/μL
- eGFR <30 ml/min per 1.73 m2
- International normalized ratio (INR) > 3
- Major trauma injury severity score (ISS) > 15
- Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
- Cardiovascular or pulmonary surgery within the last 7 days
- Actively progressing cancer treated by chemotherapeutics
- 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 uncompensated heart failure.
- 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 anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
- CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
- Life expectancy < 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Manatee Memorial Hospital / Nova Clinical Research Center
Bradenton, Florida, 32408
Hartford Healthcare
Hartford, Connecticut, 06102
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
Cumc/Nyph
New York, New York, 10032
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
ProMedica Toledo Hospital
Toledo, Ohio, 43606
About this study
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
- Conditions
- Pulmonary Embolism Acute
- Being tested
- ATC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATCDevice
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Pulmonary Embolism | Experimental | Patients undergoing mechanical thrombectomy for acute pulmonary embolism. Receives: Device: ATC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Change in RV/LV ratio from baseline
Measured: 48 hours
Safety: Composite of Major Adverse Device-Related Events
Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
Measured: 48 hours post index procedure
Secondary outcomes (1)
Safety: Composite of Major Adverse Events
Assessment of major adverse events through 30 day follow-up
Measured: 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Jan 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Why it stopped: Enrollment with the 12F device configuration is closed. Enrollment is temporarily halted pending regulatory authorization of a protocol amendment introducing a modified device configuration, after which enrollment is expected to resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies 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
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akura Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672510
- Sponsor's protocol ID
- CP-60006
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
- ClinicalTrials.gov ID
- NCT06672510
- Acronym / sponsor ID
- CP-60006
- Conditions
- Pulmonary Embolism Acute
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment with the 12F device configuration is closed. Enrollment is temporarily halted pending regulatory authorization of a protocol amendment introducing a modified device configuration, after which enrollment is expected to resume.
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Akura MedicalIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Nov 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, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Pulmonary Embolism | Experimental | Device: ATCPatients undergoing mechanical thrombectomy for acute pulmonary embolism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
Key exclusion criteria (28 listed)
- Prior PE <180 days from index procedure
- Thrombolytic use within 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary arterial pressure (PAP) > 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
- 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 |
|---|---|---|
| ATCThe ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE | Device | Patients with Acute Pulmonary Embolism |
Primary outcome
Effectiveness
Time frame: 48 hours
Change in RV/LV ratio from baseline
Safety: Composite of Major Adverse Device-Related Events
Time frame: 48 hours post index procedure
Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
1 secondary outcome
Safety: Composite of Major Adverse Events
Time frame: 30 days post index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
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Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
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Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATC in people with Pulmonary Embolism Acute, run by Akura Medical at 7 sites in United States.
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 28 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: paused, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Results are not available in the source record.
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?
Effectiveness (time frame: 48 hours). 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 31 Aug 2026.