The PEERLESS Study

Pulmonary Embolism Clinical Trial

— PEERLESS  

Official title:

The PEERLESS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111613
• Other study ID #: 21-002
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: Inari Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: April 11, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

• 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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Pulmonary Thrombo-embolism
• Thromboembolism

Intervention

Device:
• Catheter-Directed Thrombolysis
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
• FlowTriever System
Mechanical thrombectomy for pulmonary embolism

Locations

Country	Name	City	State
Germany	Universtitaetsklinikum Dusseldorf	Düsseldorf
Germany	Herzzentrum Leipzig	Leipzig
Germany	Marien Hospital Wesel GmbH	Wesel
Switzerland	Inselspital - Universitätsspital Bern	Bern
United States	Summa Akron City Hospital	Akron	Ohio
United States	Ascension St. Elizabeth Hospital	Appleton	Wisconsin
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Northwell Health	Bay Shore	New York
United States	St. Luke's University Hospital	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Gates Vascular Institute	Buffalo	New York
United States	Virtua Lourdes	Camden	New Jersey
United States	University of North Carolina Health	Chapel Hill	North Carolina
United States	MUSC Health University Medical Center	Charleston	South Carolina
United States	Mercy Health West	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	HCA Medical City Heart and Spine	Dallas	Texas
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Ascension Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	AHN Saint Vincent Hospital	Erie	Pennsylvania
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	UPMC Harrisburg	Harrisburg	Pennsylvania
United States	Houston Methodist Hospital	Houston	Texas
United States	Memorial Hermann Medical Center	Houston	Texas
United States	Ascension St. Vincent Hospital - Indianapolis	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Gundersen Health System	La Crosse	Wisconsin
United States	Radiology and Imaging Associates	Lakeland	Florida
United States	Loma Linda University Health	Loma Linda	California
United States	Norton Heralthcare	Louisville	Kentucky
United States	Baptist Health South Florida	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Ascension Saint Thomas Hospital	Nashville	Tennessee
United States	HCA TriStar Centennial Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	NewYork-Presbyterian Columbia University Irving Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Providence St. Joseph Orange	Orange	California
United States	Huntington Hospital	Pasadena	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	CentraCare St. Cloud Hospital	Saint Cloud	Minnesota
United States	Saint Louis University	Saint Louis	Missouri
United States	Methodist Main Hospital	San Antonio	Texas
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Spartanburg Regional Healthcare System	Spartanburg	South Carolina
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	University of South Florida Tampa General Hospital	Tampa	Florida
United States	Lexington Medical Center	West Columbia	South Carolina
United States	Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Inari Medical

Countries where clinical trial is conducted

United States,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:	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.	Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	Composite clinical endpoint constructed as a win ratio hierarchy of the following four 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	Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	All-cause mortality		Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	Intracranial hemorrhage (ICH)		Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	Major bleeding per ISTH definition		Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy		Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	ICU admission and ICU length of stay during the index hospitalization and following the index procedure		Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	All cause mortality		30 days from index procedure
Secondary	PE-related and all-cause readmission		30 days from index procedure
Secondary	Device and drug-related serious adverse events		30 days from index procedure
Secondary	Clinically Relevant Non-Major (CRNM) and Minor bleeding events		Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary	Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT		Baseline to 24 hour visit
Secondary	Modified Medical Research Council (mMRC) dyspnea score	The range of scores is zero to four (worse)	At 24 hour and 30 day visits
Secondary	Length of total hospital stay and post-index-procedure hospital stay		To a maximum of 30 days
Secondary	Pulmonary Embolism Quality of Life (PEmb-QOL)		At 30 day visit
Secondary	EQ-5D-5L Quality of Life		At 30 day visit

External Links

•   Study design publication