Pulmonary EmbolismNCT06588634
The PERSEVERE Study
A study testing FlowTriever System in people with Pulmonary Embolism and Pulmonary Thromboembolism, run by Inari Medical at 33 sites in 6 countries.
Trial summary
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Pulmonary Thromboembolism
- What is being tested?
- FlowTriever System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 16 Dec 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age at enrollment ≥18 years
- Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
- High-risk class of acute PE
- RV dysfunction, as defined RV/LV ratio ≥1.0
- Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards
Who cannot join
- Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
- Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
- Recent stroke (<14 days)
- Recent cranial or spinal surgery (<14 days)
- Life-threatening active bleeding or hemorrhage into a critical area
Show all 16Show fewer
- Known intracranial tumor
- End-stage medical condition with life expectancy <3 months (irrespective of the severity of acute PE), as determined by the Investigator
- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
- Current participation in another drug or device study that may interfere with the conduct of this trial
- Ventricular arrhythmias refractory to treatment at the time of enrollment
- Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
- Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
- Subject was previously enrolled in this study
- Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization
Trial locations and contacts
33 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 6 countries
United States16 sites, 16 recruiting
- Recruiting
Summa Akron
Akron, Ohio, 44304
Mark Rea, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
Wissam Jaber, MD
- Recruiting
Northwell Health
Bay Shore, New York, 11706
Kareem Niazi, MD
- Recruiting
SUNY, The University at Buffalo
Buffalo, New York, 14203
David Zlotnick, MD
- Recruiting
HCA Medical City Heart & Spine
Dallas, Texas, 75039
Srinivas Yallapragada, MD
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Gabriel Hernandez, MD
- Recruiting
HCA Tristar/Centennial
Nashville, Tennessee, 37203
Samuel Horr, MD
- Recruiting
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Natalie Millet, MD
- Recruiting
Yale University
New Haven, Connecticut, 06519
Christopher Moore, MD
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Barry Weinstock, MD
- Recruiting
Orlando Health Regional Medical Center
Orlando, Florida, 32806
Joel Garcia-Fernandez, MD
- Recruiting
UPHS Penn Health System
Philadelphia, Pennsylvania, 19104
Taisei Kobayashi, MD
Russell Rosenberg, MD
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 152123
Catalin Toma, MD
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mithun Chakravarthy, MD
- Recruiting
HCA Methodist Health San Antonio
San Antonio, Texas, 78229
Chandra Kunavarapu, MD
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Clinton Wrigley, MD
Germany7 sites, 6 recruiting
- Recruiting
Charité Campus Virchow Clinic
Berlin, 13353
Carsten Skurk, MD
- Recruiting
Klinikum Chemnitz
Chemnitz
Karim Ibrahim, MD
- Recruiting
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden
Ralf-Thorsten Hoffmann, MD
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Derk Frank, MD
- Recruiting
Universitätsmedizin Mainz
Mainz, 55131
Tommaso Gori, MD
- Recruiting
Munich LMU
München
Konstantin Stark, MD
- Active, not recruiting
Universitätsklinik Regensburg
Regensburg
France5 sites, 5 recruiting
- Recruiting
Besançon University Hospital
Besançon, 25030
Nicolas Meneveau, MD, PhD
- Recruiting
CHU Grenoble Alpes
La Tronche, 38700
Nicolas Piliero, MD
- Recruiting
Hopital Arnaud de Villeneuve, Montpellier
Montpellier
Francoise Roubille, MD
- Recruiting
CHU Nîmes Caremeau
Nîmes
Benoit Lattuca, MD, PhD
- Recruiting
Hôpital Européen Georges-Pompidou, Paris
Paris
Olivier Sanchez, MD, PhD
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron, Barcelona
Barcelona
Juan Carlos Ruiz, MD, PhD
- Recruiting
Hospital Universitario La Paz Madrid
Madrid, 28046
Raul Moreno, MD, PhD
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Gregor Leibundgut, MD
- Recruiting
University Hospital Zurich - Unispital
Zurich, Canton of Zurich, 8006
Stefano Barco, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital London
London
Gerry Coghlan, MD
About this study
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
- Conditions
- Pulmonary Embolism, Pulmonary Thromboembolism
- Being tested
- FlowTriever System, Standard of Care
- Keywords
- PE, Pulmonary Embolism, FlowTriever, CDT, Catheter Directed Thrombolysis, Anticoagulation
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowTriever SystemDevice
Mechanical thrombectomy for pulmonary embolism
Standard of CareProcedure or surgery
Standard of care treatment for pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| FlowTriever | Active comparator | Not described Receives: Device: FlowTriever System |
| Standard of Care | Active comparator | Not described Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite clinical endpoint of the following adjudicated events:
- All-cause mortality
- Cardiac arrest
- Bailout to an alternative therapeutic strategy
- Major bleeding
- ECMO life support
Measured: The earlier of initial hospital discharge or 7 days after randomization
Secondary outcomes (12)
All-cause mortality
Measured: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
Cardiac arrest
Measured: At the earlier of initial hospital discharge or 7 days post randomization
Bailout to an alternative therapeutic strategy
Measured: At the earlier of initial hospital discharge or 7 days post randomization
Major bleeding
Measured: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
ECMO life support
Measured: 7 days post-randomization
PE-related mortality
Measured: 3 months
All-cause and PE-related readmissions
Measured: 30 days and 90 days
Days alive outside hospital
Measured: 90 days
PE-related quality of life, by PEmb-QoL
Measured: 3 months
General health-related quality of life, by EQ-5D-5L
Measured: 3 months
Post-PE Impairment diagnosis
Measured: 3 months
Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Dec 2024
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Meneveau, MD PhD, Principal investigator, Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, FranceJohn M Moriarty, MD, Principal investigator, Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USAJay Giri, MD, MPH, Principal investigator, Penn Medicine, Philadelphia, PA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588634
- Sponsor's protocol ID
- 24-002
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chopard R, Hobohm L, Barco S, Bangalore S, Giri J, Mahfoud F, Moriarty J, Rosenkranz S, Sharp A, Thiele H, Toma C, Tapson VF, Markovitz CD, Rosenberg SP, Konstantinides S, Meneveau N. Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. 2026 Apr;294:107331. doi: 10.1016/j.ahj.2025.107331. Epub 2025 Dec 24.
PubMed 41453591
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PERSEVERE Study
- ClinicalTrials.gov ID
- NCT06588634
- Acronym / sponsor ID
- 24-002
- Conditions
- Pulmonary Embolism, Pulmonary Thromboembolism
- Keywords
- PE, Pulmonary Embolism, FlowTriever, CDT, Catheter Directed Thrombolysis, Anticoagulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Sep 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.
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FlowTriever | Active comparator | Device: FlowTriever System |
| Standard of Care | Active comparator | Procedure: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at enrollment ≥18 years
- Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
- High-risk class of acute PE
- RV dysfunction, as defined RV/LV ratio ≥1.0
- Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards
Key exclusion criteria (16 listed)
- Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
- Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
- Recent stroke (<14 days)
- Recent cranial or spinal surgery (<14 days)
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 |
|---|---|---|
| FlowTriever SystemMechanical thrombectomy for pulmonary embolism | Device | FlowTriever |
| Standard of CareStandard of care treatment for pulmonary embolism | Procedure or surgery | Standard of Care |
Primary outcome
Composite clinical endpoint of the following adjudicated events:
Time frame: The earlier of initial hospital discharge or 7 days after randomization
1. All-cause mortality 2. Cardiac arrest 3. Bailout to an alternative therapeutic strategy 4. Major bleeding 5. ECMO life support
12 secondary outcomes
All-cause mortality
Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
Cardiac arrest
Time frame: At the earlier of initial hospital discharge or 7 days post randomization
Bailout to an alternative therapeutic strategy
Time frame: At the earlier of initial hospital discharge or 7 days post randomization
Major bleeding
Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
ECMO life support
Time frame: 7 days post-randomization
PE-related mortality
Time frame: 3 months
All-cause and PE-related readmissions
Time frame: 30 days and 90 days
Days alive outside hospital
Time frame: 90 days
PE-related quality of life, by PEmb-QoL
Time frame: 3 months
General health-related quality of life, by EQ-5D-5L
Time frame: 3 months
Post-PE Impairment diagnosis
Time frame: 3 months
Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 41453591Chopard R, Hobohm L, Barco S, Bangalore S, Giri J, Mahfoud F, Moriarty J, Rosenkranz S, Sharp A, Thiele H, Toma C, Tapson VF, Markovitz CD, Rosenberg SP, Konstantinides S, Meneveau N. Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. 2026 Apr;294:107331. doi: 10.1016/j.ahj.2025.107331. Epub 2025 Dec 24.
- 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.
Nicolas Meneveau, MD PhD principal investigator
Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France
John M Moriarty, MD principal investigator
Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA
Jay Giri, MD, MPH principal investigator
Penn Medicine, Philadelphia, PA, USA
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowTriever System in people with Pulmonary Embolism and Pulmonary Thromboembolism, run by Inari Medical at 33 sites in 6 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, France, Spain, Switzerland and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tine Devolder (+32 476 53 88 05, tine.devolder@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical endpoint of the following adjudicated events: (time frame: The earlier of initial hospital discharge or 7 days after randomization). 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 NCT06588634, 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 8 Oct 2026.