Pulmonary EmbolismPEERLESSNCT05111613
The PEERLESS Study
A study testing Catheter-Directed Thrombolysis and FlowTriever System in people with Pulmonary Embolism and Pulmonary Thromboembolism, run by Inari Medical at 60 sites in 3 countries.
Trial summary
A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis. 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?
- Catheter-Directed Thrombolysis and FlowTriever System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 60 sitesin 3 countries
- Study dates
- 14 Feb 2022to 11 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet each of the following criteria to be included in the study:
- Age ≥ 18 years
- Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
- Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP <100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation <90%; Syncope related to PE; Elevated Lactate
- Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
- Symptom onset within 14 days of confirmed PE diagnosis
Who cannot join
- Subjects will be excluded from the study for any of the following criteria:
- Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin
- Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, including ANY of the following: cardiac arrest; OR systolic BP < 90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite adequate filling status, AND end-organ hypoperfusion; OR systolic BP < 90 mmHg or systolic BP drop ≥40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis
- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g. inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot)
- Patient has right heart clot in transit identified at baseline screening
Show all 16Show fewer
- Life expectancy < 30 days (e.g. stage 4 cancer or severe COVID-19 infection), as determined by the Investigator
- Current participation in another drug or device study that, in the Investigator's opinion, would interfere with participation in this study
- Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines
- Invasive systolic PA pressure ≥70 mmHg prior to study device entering the body
- Administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index PE event within 48 hours prior to enrollment
- Ventricular arrhythmias refractory to treatment at the time of enrollment
- Known to have heparin-induced thrombocytopenia (HIT)
- 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). This includes a contraindication to use of FlowTriever or CDT System (for example, EKOS System) per local approved labeling
- Subject has previously completed or withdrawn from this study
- Patient unwilling or unable to conduct the follow up visits per protocol.
Trial locations and contacts
60 sites in 3 countries.
60 sites in 3 countries
United States56 sites
Summa Akron City Hospital
Akron, Ohio, 44304
Ascension St. Elizabeth Hospital
Appleton, Wisconsin, 54915
Emory University
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Northwell Health
Bay Shore, New York, 11706
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Gates Vascular Institute
Buffalo, New York, 14203
Virtua Lourdes
Camden, New Jersey, 08103
University of North Carolina Health
Chapel Hill, North Carolina, 27514
MUSC Health University Medical Center
Charleston, South Carolina, 29425
Mercy Health West
Cincinnati, Ohio, 45211
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
HCA Medical City Heart and Spine
Dallas, Texas, 75243
Ascension St. John Hospital
Detroit, Michigan, 48236
Ascension Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
AHN Saint Vincent Hospital
Erie, Pennsylvania, 16544
Hackensack University Medical Center
Hackensack, New Jersey, 07601
UPMC Harrisburg
Harrisburg, Pennsylvania, 17101
Houston Methodist Hospital
Houston, Texas, 77030
Memorial Hermann Medical Center
Houston, Texas, 77030
Ascension St. Vincent Hospital - Indianapolis
Indianapolis, Indiana, 46260
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Gundersen Health System
La Crosse, Wisconsin, 54601
Radiology and Imaging Associates
Lakeland, Florida, 33801
Loma Linda University Health
Loma Linda, California, 92354
Norton Healthcare
Louisville, Kentucky, 40202
Baptist Health South Florida
Miami, Florida, 33176
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
HCA TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Ascension Saint Thomas Hospital
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NewYork-Presbyterian Columbia University Irving Medical Center
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Providence St. Joseph Orange
Orange, California, 92868
Huntington Hospital
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19108
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian
Pittsburgh, Pennsylvania, 19140
University of Rochester Medical Center
Rochester, New York, 14642
CentraCare St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Methodist Main Hospital
San Antonio, Texas, 78229
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Saint Louis University
St Louis, Missouri, 63104
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
University of South Florida Tampa General Hospital
Tampa, Florida, 33606
Lexington Medical Center
West Columbia, South Carolina, 29169
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Germany3 sites
Universtitaetsklinikum Dusseldorf
Düsseldorf
Herzzentrum Leipzig
Leipzig
Marien Hospital Wesel GmbH
Wesel
About this study
A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.
- Conditions
- Pulmonary Embolism, Pulmonary Thromboembolism
- Being tested
- Catheter-Directed Thrombolysis, FlowTriever System
- Keywords
- PE, pulmonary embolism, thrombectomy, FlowTriever, CDT, Catheter-Directed Thrombolysis
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-Directed ThrombolysisDevice
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
FlowTriever SystemDevice
Mechanical thrombectomy for pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| Randomized Controlled Trial Cohort - FlowTriever Arm | Active comparator | Mechanical thrombectomy for pulmonary embolism using the FlowTriever System. Receives: Device: FlowTriever System |
| Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm | Active comparator | Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system) Receives: Device: Catheter-Directed Thrombolysis |
| Non-Randomized Absolute Contraindication to Thrombolytics Cohort | Other | Mechanical thrombectomy for pulmonary embolism using the FlowTriever System. Receives: Device: FlowTriever System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components:
- All-cause mortality, or
- Intracranial hemorrhage (ICH), or
- Major bleeding per ISTH definition, or
- Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or
- ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure.
A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcomes (19)
Composite Clinical Endpoint Constructed as a 4-Component Win Ratio
This secondary endpoint is a composite constructed as a hierarchical win ratio of the following 4 components:
- All-cause mortality, or
- Intracranial hemorrhage (ICH), or
- Major bleeding per ISTH definition, or
- Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy
A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
All-cause Mortality
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Intracranial Hemorrhage (ICH)
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Major Bleeding Per ISTH Definition
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Clinical Deterioration Defined by Hemodynamic or Respiratory Worsening, and/or Escalation to a Bailout Therapy
Clinical deterioration is defined as documented objective hemodynamic or respiratory worsening that is new (i.e. not present at the time of enrollment).
Bailout therapy is an unplanned escalation of therapeutic measures, taken when the patient's condition has not improved or is not improving according to expectations.
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
ICU Admission During the Index Hospitalization and Following the Index Procedure
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
All Cause Mortality
Measured: 30 days from index procedure
All-cause and PE-related Readmissions
Measured: 30 days from index procedure
Device-related Serious Adverse Events
Device-related SAEs included those adjudicated by the CEC to be related to the interventional device.
Measured: Through the 30 day visit
Drug-related Serious Adverse Events
Drug-related SAEs included those adjudicated by the CEC to be related to anticoagulation and/or thrombolytics medication.
Measured: Through the 30 day visit
Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events
Measured: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Change in Right-ventricular/Left-ventricular (RV/LV) Ratio, as Measured by Echocardiography or CT
Assessments of change were made using the same imaging modality at baseline and at the 24-hour visit.
Measured: Baseline to 24 hour visit
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.
Measured: At 24 hour visit
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.
Measured: At 30 day visit
Length of Total Hospital Stay
Measured: Through 30 days post-procedure
Length of Post-index-procedure Hospital Stay
Measured: Through 30 days post-procedure
Pulmonary Embolism Quality of Life (PEmb-QOL) Score at 30 Day Visit
The Pulmonary Embolism Quality of Life (PEmb-QOL) questionnaire is used to assess the quality of life in patients with pulmonary embolism (PE). It is a disease-specific tool designed to evaluate the impact of PE on various aspects of a patient's life, including daily activities, work, social life, and emotional well-being, and is reported on a 0-100 scale with lower scores representing better quality of life.
Measured: At 30 day visit
EQ-5D-5L Quality of Life Score at 30 Day Visit
Each of the five dimensions comprising the EQ-5D-5L descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) are graded from 1 (no problems) to 5 (extreme problems). A descriptive health state is defined by combining each level for 5 dimensions into a 5-digit code (e.g., 12345) which is then mapped to the health state index score based on a country-specific value set. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health).
Measured: At 30 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start14 Feb 2022
- Primary completion1 Mar 2024
- Study completion11 Apr 2024
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.
- Publications (3)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
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wissam Jaber, MD, Principal investigator, Emory UniversityCarin Gonsalves, MD, Principal investigator, Thomas Jefferson UniversityStefan Stortecky, MD, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111613
- Sponsor's protocol ID
- 21-002
- Acronym
- PEERLESS
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2021
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gonsalves CF, Gibson CM, Stortecky S, Alvarez RA, Beam DM, Horowitz JM, Silver MJ, Toma C, Rundback JH, Rosenberg SP, Markovitz CD, Tu T, Jaber WA. Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study. Am Heart J. 2023 Dec;266:128-137. doi: 10.1016/j.ahj.2023.09.002. Epub 2023 Sep 12.
PubMed 37703948Jaber WA, Gonsalves CF, Stortecky S, Horr S, Pappas O, Gandhi RT, Pereira K, Giri J, Khandhar SJ, Ammar KA, Lasorda DM, Stegman B, Busch L, Dexter DJ 2nd, Azene EM, Daga N, Elmasri F, Kunavarapu CR, Rea ME, Rossi JS, Campbell J, Lindquist J, Raskin A, Smith JC, Tamlyn TM, Hernandez GA, Rali P, Schmidt TR, Bruckel JT, Camacho JC, Li J, Selim S, Toma C, Basra SS, Bergmark BA, Khalsa B, Zlotnick DM, Castle J, O'Connor DJ, Gibson CM; PEERLESS Committees and Investigators*. Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial. Circulation. 2025 Feb 4;151(5):260-273. doi: 10.1161/CIRCULATIONAHA.124.072364. Epub 2024 Oct 29.
PubMed 39470698Gonsalves CF, Stortecky S, Horr S, Pappas O, Gandhi RT, Pereira K, Giri J, Khandhar SJ, Azene EM, Elmasri F, Lindquist J, Jaber WA. Evaluation of Catheter-Directed Thrombolysis Device Type and Dosing on Treatment Outcomes in Intermediate-Risk Pulmonary Embolism: A PEERLESS Randomized Controlled Trial Post Hoc Analysis. J Vasc Interv Radiol. 2026 Jan;37(1):107866. doi: 10.1016/j.jvir.2025.09.037. Epub 2025 Oct 8.
PubMed 41072848
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PEERLESS Study
- ClinicalTrials.gov ID
- NCT05111613
- Acronym / sponsor ID
- PEERLESS / 21-002
- Conditions
- Pulmonary Embolism, Pulmonary Thromboembolism
- Keywords
- PE, pulmonary embolism, thrombectomy, FlowTriever, CDT, Catheter-Directed Thrombolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized Controlled Trial Cohort - FlowTriever Arm | Active comparator | Device: FlowTriever SystemMechanical thrombectomy for pulmonary embolism using the FlowTriever System. |
| Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm | Active comparator | Device: Catheter-Directed ThrombolysisCatheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system) |
| Non-Randomized Absolute Contraindication to Thrombolytics Cohort | Other | Device: FlowTriever SystemMechanical thrombectomy for pulmonary embolism using the FlowTriever System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
- Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP <100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation <90%; Syncope related to PE; Elevated Lactate
- Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
- Symptom onset within 14 days of confirmed PE diagnosis
Key exclusion criteria (16 listed)
- Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin
- Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, including ANY of the following: cardiac arrest; OR systolic BP < 90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite adequate filling status, AND end-organ hypoperfusion; OR systolic BP < 90 mmHg or systolic BP drop ≥40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis
- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g. inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot)
- Patient has right heart clot in transit identified at baseline screening
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 |
|---|---|---|
| Catheter-Directed ThrombolysisCatheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system) | Device | Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm |
| FlowTriever SystemMechanical thrombectomy for pulmonary embolism | Device | Non-Randomized Absolute Contraindication to Thrombolytics Cohort, Randomized Controlled Trial Cohort - FlowTriever Arm |
Primary outcome
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
19 secondary outcomes
Composite Clinical Endpoint Constructed as a 4-Component Win Ratio
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
All-cause Mortality
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Intracranial Hemorrhage (ICH)
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Major Bleeding Per ISTH Definition
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Clinical Deterioration Defined by Hemodynamic or Respiratory Worsening, and/or Escalation to a Bailout Therapy
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
ICU Admission During the Index Hospitalization and Following the Index Procedure
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
All Cause Mortality
Time frame: 30 days from index procedure
All-cause and PE-related Readmissions
Time frame: 30 days from index procedure
Device-related Serious Adverse Events
Time frame: Through the 30 day visit
Drug-related Serious Adverse Events
Time frame: Through the 30 day visit
Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Change in Right-ventricular/Left-ventricular (RV/LV) Ratio, as Measured by Echocardiography or CT
Time frame: Baseline to 24 hour visit
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
Time frame: At 24 hour visit
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
Time frame: At 30 day visit
Length of Total Hospital Stay
Time frame: Through 30 days post-procedure
Length of Post-index-procedure Hospital Stay
Time frame: Through 30 days post-procedure
Pulmonary Embolism Quality of Life (PEmb-QOL) Score at 30 Day Visit
Time frame: At 30 day visit
EQ-5D-5L Quality of Life Score at 30 Day Visit
Time frame: At 30 day visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37703948Gonsalves CF, Gibson CM, Stortecky S, Alvarez RA, Beam DM, Horowitz JM, Silver MJ, Toma C, Rundback JH, Rosenberg SP, Markovitz CD, Tu T, Jaber WA. Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study. Am Heart J. 2023 Dec;266:128-137. doi: 10.1016/j.ahj.2023.09.002. Epub 2023 Sep 12.
- Results publication: PubMed 39470698Jaber WA, Gonsalves CF, Stortecky S, Horr S, Pappas O, Gandhi RT, Pereira K, Giri J, Khandhar SJ, Ammar KA, Lasorda DM, Stegman B, Busch L, Dexter DJ 2nd, Azene EM, Daga N, Elmasri F, Kunavarapu CR, Rea ME, Rossi JS, Campbell J, Lindquist J, Raskin A, Smith JC, Tamlyn TM, Hernandez GA, Rali P, Schmidt TR, Bruckel JT, Camacho JC, Li J, Selim S, Toma C, Basra SS, Bergmark BA, Khalsa B, Zlotnick DM, Castle J, O'Connor DJ, Gibson CM; PEERLESS Committees and Investigators*. Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial. Circulation. 2025 Feb 4;151(5):260-273. doi: 10.1161/CIRCULATIONAHA.124.072364. Epub 2024 Oct 29.
- Derived from this study: PubMed 41072848Gonsalves CF, Stortecky S, Horr S, Pappas O, Gandhi RT, Pereira K, Giri J, Khandhar SJ, Azene EM, Elmasri F, Lindquist J, Jaber WA. Evaluation of Catheter-Directed Thrombolysis Device Type and Dosing on Treatment Outcomes in Intermediate-Risk Pulmonary Embolism: A PEERLESS Randomized Controlled Trial Post Hoc Analysis. J Vasc Interv Radiol. 2026 Jan;37(1):107866. doi: 10.1016/j.jvir.2025.09.037. Epub 2025 Oct 8.
- 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
Carin Gonsalves, MD principal investigator
Thomas Jefferson University
Stefan Stortecky, MD principal investigator
Bern University Hospital
60 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter-Directed Thrombolysis and FlowTriever System in people with Pulmonary Embolism and Pulmonary Thromboembolism, run by Inari Medical at 60 sites in 3 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 6 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: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Germany, Switzerland. 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 13 Nov 2025). 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?
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio (time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner). 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 NCT05111613, which also lists 3 linked publications.
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 13 Nov 2025.