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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05111613




Registration number
NCT05111613
Ethics application status
Date submitted
15/10/2021
Date registered
8/11/2021
Date last updated
1/10/2024

Titles & IDs
Public title
The PEERLESS Study
Scientific title
The PEERLESS Study
Secondary ID [1] 0 0
21-002
Universal Trial Number (UTN)
Trial acronym
PEERLESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Pulmonary Thrombo-embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Catheter-Directed Thrombolysis
Treatment: Devices - FlowTriever System

Active comparator: Randomized Controlled Trial Cohort - FlowTriever Arm - Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Active comparator: Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm - Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)

Other: Non-Randomized Absolute Contraindication to Thrombolytics Cohort - Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.


Treatment: Devices: Catheter-Directed Thrombolysis
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)

Treatment: Devices: FlowTriever System
Mechanical thrombectomy for pulmonary embolism
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Timepoint [1] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [1] 0 0
Composite clinical endpoint constructed as a win ratio hierarchy of the following four components:
Timepoint [1] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [2] 0 0
All-cause mortality
Timepoint [2] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [3] 0 0
Intracranial hemorrhage (ICH)
Timepoint [3] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [4] 0 0
Major bleeding per ISTH definition
Timepoint [4] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [5] 0 0
Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy
Timepoint [5] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [6] 0 0
ICU admission and ICU length of stay during the index hospitalization and following the index procedure
Timepoint [6] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [7] 0 0
All cause mortality
Timepoint [7] 0 0
30 days from index procedure
Secondary outcome [8] 0 0
PE-related and all-cause readmission
Timepoint [8] 0 0
30 days from index procedure
Secondary outcome [9] 0 0
Device and drug-related serious adverse events
Timepoint [9] 0 0
30 days from index procedure
Secondary outcome [10] 0 0
Clinically Relevant Non-Major (CRNM) and Minor bleeding events
Timepoint [10] 0 0
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary outcome [11] 0 0
Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT
Timepoint [11] 0 0
Baseline to 24 hour visit
Secondary outcome [12] 0 0
Modified Medical Research Council (mMRC) dyspnea score
Timepoint [12] 0 0
At 24 hour and 30 day visits
Secondary outcome [13] 0 0
Length of total hospital stay and post-index-procedure hospital stay
Timepoint [13] 0 0
To a maximum of 30 days
Secondary outcome [14] 0 0
Pulmonary Embolism Quality of Life (PEmb-QOL)
Timepoint [14] 0 0
At 30 day visit
Secondary outcome [15] 0 0
EQ-5D-5L Quality of Life
Timepoint [15] 0 0
At 30 day visit

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2024
Sample size
Target
Accrual to date
Final
550
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Germany
State/province [24] 0 0
Düsseldorf
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Germany
State/province [26] 0 0
Wesel
Country [27] 0 0
Switzerland
State/province [27] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inari Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05111613
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Wissam Jaber, MD
Address 0 0
Emory University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05111613