RECRUITING

The PEERLESS II Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.

Official Title

PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism

Quick Facts

Study Start:2023-11-17

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06055920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age at enrollment ≥ 18 years 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality 3. RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis 4. At least two additional risk factors, identified by at least one measure in two separate categories noted below: 5. Symptom onset within 14 days of confirmed PE diagnosis 6. Willing and able to provide informed consent	1. Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin 2. Presentation with hemodynamic instability\* that meets the high-risk PE definition in the 2019 ESC Guidelines1, including ANY of the following 1. Cardiac arrest OR 2. Systolic BP \< 90 mmHg or vasopressors required to achieve a BP ≥ 90 mmHg despite adequate filling status, AND end-organ hypoperfusion OR 3. 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 \* Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation. 3. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated 4. 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) 5. End stage medical condition with life expectancy \< 3 months, as determined by the Investigator 6. Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study 7. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1 8. If objective testing was performed\, estimated RV systolic pressure \> 70 mmHg on standard of care echocardiography \ If clinical suspicion of acute-on-chronic PE, chronic obstruction, or chronic thromboembolism, echocardiographic estimated RVSP must be confirmed ≤70 mmHg to meet eligibility. Pressure assessment not required if Investigator attests to absence of such clinical suspicion 9. Administration of advanced therapies (thrombolytic bolus, thrombolytic drip/infusion, catheter-directed thrombolytic therapy, mechanical thrombectomy, or ECMO) for the index PE event within 30 days prior to enrollment 10. Ventricular arrhythmias refractory to treatment at the time of enrollment 11. Known to have heparin-induced thrombocytopenia (HIT) 12. 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 System per local approved labeling 13. Subject is currently pregnant 14. Subject has previously completed or withdrawn from this study

Inclusion Criteria

Exclusion Criteria

1. Age at enrollment ≥ 18 years
2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality
3. RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis
4. At least two additional risk factors, identified by at least one measure in two separate categories noted below:
5. Symptom onset within 14 days of confirmed PE diagnosis
6. Willing and able to provide informed consent

1. Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin
2. Presentation with hemodynamic instability\* that meets the high-risk PE definition in the 2019 ESC Guidelines1, including ANY of the following
1. Cardiac arrest OR
2. Systolic BP \< 90 mmHg or vasopressors required to achieve a BP ≥ 90 mmHg despite adequate filling status, AND end-organ hypoperfusion OR
3. 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 \* Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation.
3. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
4. 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)
5. End stage medical condition with life expectancy \< 3 months, as determined by the Investigator
6. Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study
7. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1
8. If objective testing was performed\*, estimated RV systolic pressure \> 70 mmHg on standard of care echocardiography \* If clinical suspicion of acute-on-chronic PE, chronic obstruction, or chronic thromboembolism, echocardiographic estimated RVSP must be confirmed ≤70 mmHg to meet eligibility. Pressure assessment not required if Investigator attests to absence of such clinical suspicion
9. Administration of advanced therapies (thrombolytic bolus, thrombolytic drip/infusion, catheter-directed thrombolytic therapy, mechanical thrombectomy, or ECMO) for the index PE event within 30 days prior to enrollment
10. Ventricular arrhythmias refractory to treatment at the time of enrollment
11. Known to have heparin-induced thrombocytopenia (HIT)
12. 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 System per local approved labeling
13. Subject is currently pregnant
14. Subject has previously completed or withdrawn from this study

Contacts and Locations

Study Contact

Cassandra Gamble

CONTACT

651-900-5294

cassandra.gamble@inarimedical.com

Principal Investigator

Frances Mae West, MD

PRINCIPAL_INVESTIGATOR

Jefferson Health,

Jay Giri, MD

PRINCIPAL_INVESTIGATOR

Penn Medicine

Bernhard Gebauer, MD

PRINCIPAL_INVESTIGATOR

Charité University Hospital Berlin

Felix Mahfoud, MD

PRINCIPAL_INVESTIGATOR

Saarland University Hospital Homburg

Study Locations (Sites)

UAB Division of Cardiovascular Disease

Birmingham, Alabama, 35205

United States

Brookwood Medical Center

Birmingham, Alabama, 35243

United States

Huntington Memorial Hospital

Pasadena, California, 91105

United States

University of Colorado, Denver

Aurora, Colorado, 80045

United States

Yale University

New Haven, Connecticut, 06520

United States

HCA FL Largo Medical Center

Largo, Florida, 33770

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Emory University

Atlanta, Georgia, 30322

United States

Northwestern University

Chicago, Illinois, 60611

United States

Baptist Health Louisville

Louisville, Kentucky, 40207

United States

McLaren Greater Lansing

Lansing, Michigan, 48910

United States

Sparrow Hospital

Lansing, Michigan, 48912

United States

Metropolitan Heart & Vascular Institute

Coon Rapids, Minnesota, 55433

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

Nebraska Medical Center

Omaha, Nebraska, 68105

United States

Virtua Health

Camden, New Jersey, 08103

United States

Valley Health

Ridgewood, New Jersey, 07450

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

SUNY, The University of Buffalo/Gates Vascular

Buffalo, New York, 14203

United States

Northwell Health

New York, New York, 10075

United States

Jamaica Hospital

Queens, New York, 11418

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

Stony Brook University Hospital

Stony Brook, New York, 11794

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210

United States

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015

United States

AHN Saint Vincent Hospital

Erie, Pennsylvania, 16505

United States

UPMC Hamot

Erie, Pennsylvania, 16507

United States

UPMC Harrisburg

Harrisburg, Pennsylvania, 17101

United States

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144

United States

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212

United States

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213

United States

Wellspan York Hospital

York, Pennsylvania, 17403

United States

HCA Tristar

Brentwood, Tennessee, 37027

United States

UTMC Knoxville

Knoxville, Tennessee, 37920

United States

Ascension Saint Thomas Hospital Midtown

Nashville, Tennessee, 37203

United States

Parkland Hospital

Dallas, Texas, 75235

United States

Texas Health Harris Methodist Hospital

Fort Worth, Texas, 76104

United States

Texas Tech / UMC

Lubbock, Texas, 79430

United States

The Heart Hospital of Baylor Plano

Plano, Texas, 75093

United States

Methodist Main Hospital

San Antonio, Texas, 78229

United States

Baylor Scott & White - Temple

Temple, Texas, 76508

United States

Inova Fairfax

Falls Church, Virginia, 22042

United States

Sentara Vascular Specialists

Norfolk, Virginia, 23507

United States

Carilion Roanoke

Roanoke, Virginia, 24014

United States

University of Washington

Seattle, Washington, 98195

United States

Providence Sacred Heart

Spokane, Washington, 99204

United States

Charleston Area Medical Center

Charleston, West Virginia, 25304

United States

West Virginia University Ruby Memorial Hospital

Morgantown, West Virginia, 26506

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Collaborators and Investigators

Sponsor: Inari Medical

Frances Mae West, MD, PRINCIPAL_INVESTIGATOR, Jefferson Health,
Jay Giri, MD, PRINCIPAL_INVESTIGATOR, Penn Medicine
Bernhard Gebauer, MD, PRINCIPAL_INVESTIGATOR, Charité University Hospital Berlin
Felix Mahfoud, MD, PRINCIPAL_INVESTIGATOR, Saarland University Hospital Homburg

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-11-17

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Embolism