Pulmonary Embolism AcuteNCT06152341
Safety and Effectiveness of the ATC System in the Treatment of Acute PE
A study testing ATC System in people with Pulmonary Embolism Acute, run by Akura Medical at 3 sites in 2 countries.
Trial summary
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- ATC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 May 2024to May 2027
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 and ≤ 90 years old
- Clinical signs and symptoms consistent with acute PE for < 14 days
- CTA evidence of proximal PE
- RV/LV ratio > 0.9
- Systolic BP ≥90 mmHg without the need for vasopressors
- Stable heart rate (HR) < 130 BPM prior to procedure
- Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
- Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
Who cannot join
- Prior PE < 180 days from index procedure
- Thrombolytic use < 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
- FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
- Hematocrit <28%
- Platelets count <100,000/µL
Show all 26Show fewer
- Serum creatinine >1.8 mg/dL
- International normalized ratio (INR) >3
- Major trauma injury severity score (ISS) >15 prior to screening assessment
- Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
- Cardiovascular or pulmonary surgery within 7 days of index procedure
- 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 decompensated 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
- Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
- Life expectancy <90 days, as determined by investigator such as 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
3 sites in 2 countries.
3 sites in 2 countries
Brazil2 sites
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-000
Instituto do Coracao
São Paulo, São Paulo, 05403-000
Dominican Republic1 site
Centro de Intervenciones Cardiovasculares
Santiago de los Caballeros, Santiago Province
About this study
Official title: Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).
- Conditions
- Pulmonary Embolism Acute
- Being tested
- ATC System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATC SystemDevice
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 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Change in RV/LV ratio
Measured: 48 hours post index procedure
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 posted30 Nov 2023
- Study start15 May 2024
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Enrollment temporarily paused pending device resupply to sites. Enrollment is expected to resume to reach the target sample size following the recently approved protocol amendment. The pause is not related to subject safety or device performance.
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
- 30 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
- NCT06152341
- Sponsor's protocol ID
- CP-60003
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 ATC System in the Treatment of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06152341
- Acronym / sponsor ID
- CP-60003
- Conditions
- Pulmonary Embolism Acute
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment temporarily paused pending device resupply to sites. Enrollment is expected to resume to reach the target sample size following the recently approved protocol amendment. The pause is not related to subject safety or device performance.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Akura MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Nov 2023 (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 the ATC 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: ATC SystemPatients undergoing mechanical thrombectomy for acute pulmonary embolism. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is ≥ 18 and ≤ 90 years old
- Clinical signs and symptoms consistent with acute PE for < 14 days
- CTA evidence of proximal PE
- RV/LV ratio > 0.9
- Systolic BP ≥90 mmHg without the need for vasopressors
Key exclusion criteria (26 listed)
- Prior PE < 180 days from index procedure
- Thrombolytic use < 30 days prior to baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
- FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
- Hematocrit <28%
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 |
|---|---|---|
| ATC SystemThe 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 post index procedure
Change in RV/LV ratio
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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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATC System in people with Pulmonary Embolism Acute, run by Akura Medical at 3 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 8 inclusion and 26 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 3 sites in Brazil, Dominican Republic. 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 post index procedure). 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.