Pulmonary EmbolismNCT05907564
Aventus Thrombectomy System Pulmonary Embolism Clinical Study
A study testing Thrombectomy in people with Pulmonary Embolism and Embolism, run by Inquis Medical, Inc. at 26 sites in United States.
Trial summary
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism, Embolism, Embolism and Thrombosis
- What is being tested?
- Thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 26 sitesUnited States
- Study dates
- 20 Sep 2023to Feb 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years
- 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
- Subject is willing and able to comply with all protocol required follow-up visits
- PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure
- PE diagnosis ≤ 48 hours prior to index procedure
- CTA (computed tomography angiography) evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
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- CTA evidence of dilated RV (right ventricle) with an RV/LV (left ventricle) ratio of ≥ 0.9 at baseline based on Investigator determination
- Systolic blood pressure (SBP) ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)
- Stable heart rate < 130 BPM prior to index procedure
- Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
Who cannot join
- Prior PE ≤ 180 days from index procedure
- Current hospitalization for other condition(s)
- Thrombolytic use ≤ 14 days of baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit < 28% within 6 hours of index procedure
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- Platelets < 100,000/μL
- Serum creatinine > 1.8 mg/dL
- International normalized ratio (INR) > 3
- Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure
- Cardiovascular or pulmonary surgery ≤ 7 days prior to 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 uncompensated heart failure
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- History of heparin-induced thrombocytopenia (HIT)
- Any 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 aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus
- Life expectancy of < 90 days, as determined by Investigator
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial
- Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
- Subject on extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Emory University
Atlanta, Georgia, 30322
Ascension Seton
Austin, Texas, 78705
McLaren Health Care
Bay City, Michigan, 48708
Northwestern University
Chicago, Illinois, 60611
University Hospitals
Cleveland, Ohio, 44106
OhioHealth Research Institute
Columbus, Ohio, 43214
Henry Ford Hospital
Detroit, Michigan, 48202
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
NorthBay Medical Center
Fairfield, California, 94533
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06102
Ascension St. Vincent
Indianapolis, Indiana, 46260
MemorialCare
Long Beach, California, 90806
El Camino Health
Mountain View, California, 94040
Centennial Medical Center (HCA)
Nashville, Tennessee, 37203
Ochsner Health
New Orleans, Louisiana, 70121
Ichan School of Medicine at Mount Sinai
New York, New York, 10019
The Miriam Hospital
Providence, Rhode Island, 02906
Sutter Health
Sacramento, California, 95816
CentraCare Heart and Vascular
Saint Cloud, Minnesota, 56303
Honor Health
Scottsdale, Arizona, 85258
Ascension Providence
Southfield, Michigan, 48075
Holy Name Medical Center
Teaneck, New Jersey, 07666
ProMedica - Jobst Vascular
Toledo, Ohio, 43606
Ascension St. John
Tulsa, Oklahoma, 74006
Medstar
Washington D.C., District of Columbia, 20010
About this study
Official title: Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
- Conditions
- Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases
- Being tested
- Thrombectomy
- Keywords
- Pulmonary Embolism, Clot, Thromboembolism, Thrombectomy, Right Heart Strain
- Medical subject headings
- Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyDevice
Use of Aventus Thrombectomy System to treat pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Device: Aventus Thrombectomy System Receives: Device: Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RV/LV Ratio
Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline
Measured: at 48hrs compared to baseline
Device Related Major Adverse Event Rate
Composite of device related MAEs (major adverse events) including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury
Measured: From Index Procedure to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start20 Sep 2023
- Primary completion20 Feb 2025
- Study completionFeb 2027 (estimated)
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inquis Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wissam Jaber, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907564
- Sponsor's protocol ID
- CT-0001
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2023
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05907564
- Acronym / sponsor ID
- CT-0001
- Conditions
- Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases
- Keywords
- Pulmonary Embolism, Clot, Thromboembolism, Thrombectomy, Right Heart Strain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Inquis Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute 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 |
|---|---|---|
| Single Arm | Experimental | Device: ThrombectomyDevice: Aventus Thrombectomy System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 and ≤ 80 years
- 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
- Subject is willing and able to comply with all protocol required follow-up visits
- PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure
- PE diagnosis ≤ 48 hours prior to index procedure
Key exclusion criteria (28 listed)
- Prior PE ≤ 180 days from index procedure
- Current hospitalization for other condition(s)
- Thrombolytic use ≤ 14 days of baseline CTA
- Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
- 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 |
|---|---|---|
| ThrombectomyUse of Aventus Thrombectomy System to treat pulmonary embolism | Device | Single Arm |
Primary outcome
Change in RV/LV Ratio
Time frame: at 48hrs compared to baseline
Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline
Device Related Major Adverse Event Rate
Time frame: From Index Procedure to 48 hours
Composite of device related MAEs (major adverse events) including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Wissam Jaber, MD principal investigator
Emory University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombectomy in people with Pulmonary Embolism and Embolism, run by Inquis Medical, Inc. at 26 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 10 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Yes. Results are posted in the registry (first posted 4 Sep 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 RV/LV Ratio (time frame: at 48hrs compared to baseline). 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 4 Sep 2026.