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The PEERLESS Study (PEERLESS)

Primary Purpose

Pulmonary Embolism, Pulmonary Thrombo-embolism

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Catheter-Directed Thrombolysis
FlowTriever System
Sponsored by
Inari Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring PE, pulmonary embolism, thrombectomy, FlowTriever, CDT, Catheter-Directed Thrombolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Classification of intermediate-high-risk PE by ESC Guidelines 2019, 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 elevated cardiac troponin levels
  • 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)
  • Subject has previously completed or withdrawn from this study
  • Patient unwilling or unable to conduct the follow up visits per protocol.

Sites / Locations

  • Loma Linda University HealthRecruiting
  • Providence St. Joseph OrangeRecruiting
  • Huntington HospitalRecruiting
  • University of Colorado HospitalRecruiting
  • Radiology and Imaging AssociatesRecruiting
  • Baptist Health South FloridaRecruiting
  • Sarasota Memorial HospitalRecruiting
  • Tallahassee Memorial HospitalRecruiting
  • University of South Florida Tampa General HospitalRecruiting
  • Emory UniversityRecruiting
  • Ascension Alexian Brothers Medical CenterRecruiting
  • Advocate Christ Medical CenterRecruiting
  • Ascension St. Vincent Hospital - Indianapolis
  • Norton HeralthcareRecruiting
  • Brigham and Women's HospitalRecruiting
  • Beth Israel Deaconess Medical Center
  • Ascension St. John HospitalRecruiting
  • CentraCare St. Cloud HospitalRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Saint Luke's Hospital of Kansas CityRecruiting
  • Saint Louis UniversityRecruiting
  • Virtua LourdesRecruiting
  • Hackensack University Medical CenterRecruiting
  • Northwell HealthRecruiting
  • Gates Vascular InstituteRecruiting
  • NewYork-Presbyterian Columbia University Irving Medical CenterRecruiting
  • University of Rochester Medical CenterRecruiting
  • University of North Carolina HealthRecruiting
  • Novant Health New Hanover Regional Medical CenterRecruiting
  • Summa Akron City HospitalRecruiting
  • Mercy Health WestRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • OhioHealth Riverside Methodist HospitalRecruiting
  • St. Luke's University HospitalRecruiting
  • AHN Saint Vincent HospitalRecruiting
  • UPMC HarrisburgRecruiting
  • University of PennsylvaniaRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • Temple University HospitalRecruiting
  • Allegheny General HospitalRecruiting
  • UPMC PresbyterianRecruiting
  • MUSC Health University Medical CenterRecruiting
  • Spartanburg Regional Healthcare SystemRecruiting
  • Lexington Medical CenterRecruiting
  • HCA TriStar Centennial Medical CenterRecruiting
  • Ascension Saint Thomas HospitalRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • HCA Medical City Heart and SpineRecruiting
  • Houston Methodist HospitalRecruiting
  • Memorial Hermann Medical CenterRecruiting
  • Methodist Main HospitalRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Providence Sacred Heart Medical CenterRecruiting
  • Ascension St. Elizabeth HospitalRecruiting
  • Gundersen Health SystemRecruiting
  • Aurora St. Luke's Medical CenterRecruiting
  • Universtitaetsklinikum DusseldorfRecruiting
  • Herzzentrum LeipzigRecruiting
  • Marien Hospital Wesel GmbHRecruiting
  • Inselspital - Universitätsspital BernRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Randomized Controlled Trial Cohort - FlowTriever Arm

Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm

Non-Randomized Absolute Contraindication to Thrombolytics Cohort

Arm Description

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

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

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
All-cause mortality
Intracranial hemorrhage (ICH)
Major bleeding per ISTH definition
Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy
ICU admission and ICU length of stay during the index hospitalization and following the index procedure
All cause mortality
PE-related and all-cause readmission
Device and drug-related serious adverse events
Clinically Relevant Non-Major (CRNM) and Minor bleeding events
Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT
Modified Medical Research Council (mMRC) dyspnea score
The range of scores is zero to four (worse)
Length of total hospital stay and post-index-procedure hospital stay
Pulmonary Embolism Quality of Life (PEmb-QOL)
EQ-5D-5L Quality of Life

Full Information

First Posted
October 15, 2021
Last Updated
September 26, 2023
Sponsor
Inari Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05111613
Brief Title
The PEERLESS Study
Acronym
PEERLESS
Official Title
The PEERLESS Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inari Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Pulmonary Thrombo-embolism
Keywords
PE, pulmonary embolism, thrombectomy, FlowTriever, CDT, Catheter-Directed Thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized Controlled Trial Cohort - FlowTriever Arm
Arm Type
Active Comparator
Arm Description
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Arm Title
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Arm Type
Active Comparator
Arm Description
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Arm Title
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Arm Type
Other
Arm Description
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Intervention Type
Device
Intervention Name(s)
Catheter-Directed Thrombolysis
Intervention Description
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Intervention Type
Device
Intervention Name(s)
FlowTriever System
Intervention Description
Mechanical thrombectomy for pulmonary embolism
Primary Outcome Measure Information:
Title
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Description
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.
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Secondary Outcome Measure Information:
Title
Composite clinical endpoint constructed as a win ratio hierarchy of the following four components:
Description
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
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Title
All-cause mortality
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Title
Intracranial hemorrhage (ICH)
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Title
Major bleeding per ISTH definition
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Title
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
Title
ICU admission and ICU length of stay during the index hospitalization and following the index procedure
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Title
All cause mortality
Time Frame
30 days from index procedure
Title
PE-related and all-cause readmission
Time Frame
30 days from index procedure
Title
Device and drug-related serious adverse events
Time Frame
30 days from index procedure
Title
Clinically Relevant Non-Major (CRNM) and Minor bleeding events
Time Frame
Hospital discharge or at 7 days after the index procedure, whichever is sooner
Title
Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT
Time Frame
Baseline to 24 hour visit
Title
Modified Medical Research Council (mMRC) dyspnea score
Description
The range of scores is zero to four (worse)
Time Frame
At 24 hour and 30 day visits
Title
Length of total hospital stay and post-index-procedure hospital stay
Time Frame
To a maximum of 30 days
Title
Pulmonary Embolism Quality of Life (PEmb-QOL)
Time Frame
At 30 day visit
Title
EQ-5D-5L Quality of Life
Time Frame
At 30 day visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Skorupa
Phone
651-492-2654
Email
scott.skorupa@inarimedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wissam Jaber, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carin Gonsalves, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Stortecky, MD
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Smith, MD
Facility Name
Providence St. Joseph Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Khalsa, MD
Facility Name
Huntington Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikhil Daga, MD
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lindquist, MD
Facility Name
Radiology and Imaging Associates
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fakhir Elmasri, MD
Facility Name
Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ripal Gandhi, MD
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Lee, MD
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Dixon, MD
Facility Name
University of South Florida Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenn Hoots, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam Jaber, MD
Facility Name
Ascension Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Pop, MD
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Kassas, MD
Facility Name
Ascension St. Vincent Hospital - Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Heralthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rothschild, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Bergmark, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Kaki, MD
Facility Name
CentraCare St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Stegman, MD
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Hernandez, MD
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Bunte, MD
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Pereira, MD
Facility Name
Virtua Lourdes
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luai Tabaza, MD
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David O'Connor, MD
Facility Name
Northwell Health
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samy Selim, MD
Facility Name
Gates Vascular Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zlotnick, MD
Facility Name
NewYork-Presbyterian Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjum Sethi, MD
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bruckel, MD MPH
Facility Name
University of North Carolina Health
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Rossi, MD
Facility Name
Novant Health New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Lewis, MD
Facility Name
Summa Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Rea, MD
Facility Name
Mercy Health West
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Raskin, MD
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li, MD
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Campbell, MD
Facility Name
St. Luke's University Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Redstone, MD
Facility Name
AHN Saint Vincent Hospital
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orestis Pappas, MD
Facility Name
UPMC Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torrey Schmidt, DO
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameer Khandhar, MD
First Name & Middle Initial & Last Name & Degree
Jay Giri, MD
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carin Gonsalves, MD
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parth Rali, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave Lasorda, MD
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalin Toma, MD
Facility Name
MUSC Health University Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Todoran, MD, MS
Facility Name
Spartanburg Regional Healthcare System
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Brown, MD
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Leonardi, MD
Facility Name
HCA TriStar Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Horr, MD
Facility Name
Ascension Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmy Kerrigan, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pete Fong, MD
Facility Name
HCA Medical City Heart and Spine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivas Yallapragada, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charudatta Bavare, MD MPH
Facility Name
Memorial Hermann Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukhdeep Basra, MD
Facility Name
Methodist Main Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandra Kunavarapu, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Dexter, MD
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Castle, MD
Facility Name
Ascension St. Elizabeth Hospital
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Tamlyn, MD
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezana Azene, MD PhD
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramagopal Tumuluri, MD
Facility Name
Universtitaetsklinikum Dusseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Lucas Busch, MD
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Fengler, MD
Facility Name
Marien Hospital Wesel GmbH
City
Wesel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Tiefenbacher, MD
Facility Name
Inselspital - Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Stortecky, MD MPH

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://doi.org/10.1016/j.ahj.2023.09.002
Description
Study design publication

Learn more about this trial

The PEERLESS Study

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