The PEERLESS II Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Inari Medical
Study ID
NCT06055920
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Embolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FlowTriever System — DEVICE
    Mechanical Thrombectomy for pulmonary embolism
  • Anticoagulation Agents — DRUG
    Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. Anticoagulants are a group of medications that decrease your blood's ability to clot.

Study Details

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

Key Dates

Start date
Nov 17, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FlowTriever
    Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
  • Active Comparator: Anticoagulation
    Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. Anticoagulants are a group of medications that decrease your blood's ability to clot.

Primary Outcome Measure

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization: [ Time Frame: through discharge or 30 days, whichever is sooner / dyspnea at 48 hours ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
Brookwood Medical CenterBirminghamAlabama35243-
UAB Division of Cardiovascular DiseaseBirminghamAlabama35205
Samuel McElwee, MD
Huntington Memorial HospitalPasadenaCalifornia91105
Nikhil Daga, MD
University of Colorado, DenverAuroraColorado80045
Todd Bull, MD
Yale UniversityNew HavenConnecticut06520
Akhil Khosla, MD
HCA FL Largo Medical CenterLargoFlorida33770-
AdventHealth OrlandoOrlandoFlorida32803
Barry Weinstock, MD
Emory UniversityAtlantaGeorgia30322
Wissam Jaber, MD
Northwestern UniversityChicagoIllinois60611
Daniel Schimmel, MD
Baptist Health LouisvilleLouisvilleKentucky40207-
McLaren Greater LansingLansingMichigan48910
Ibrahim Shah, MD
Metropolitan Heart & Vascular InstituteCoon RapidsMinnesota55433-
Mayo ClinicRochesterMinnesota55905-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Mercy Hospital SpringfieldSpringfieldMissouri65804
Madhu Kalyan Pendurthi, MD
Nebraska Medical CenterOmahaNebraska68105
Jason Cook, MD
Virtua HealthCamdenNew Jersey08103
Rita Butler, MD
Valley HealthRidgewoodNew Jersey07450-
SUNY, The University of Buffalo/Gates VascularBuffaloNew York14203
David Zlotnick, MD
Northwell HealthNew YorkNew York10075
Bushra Mina, MD
Jamaica HospitalQueensNew York11418
Zoran Lasic, MD
University of Rochester Medical CenterRochesterNew York14642
Jeffrey Bruckel, MD
Stony Brook University HospitalStony BrookNew York11794
Daniel Ohngemach, MD
Montefiore Medical CenterThe BronxNew York10467
Asma Khaliq, MD
University of Cincinnati Medical CenterCincinnatiOhio45219
Rishi Sukhija, MD
The Cleveland Clinic FoundationClevelandOhio44195
Aravinda Nanjundappa, MD
Ohio State University - Wexner Medical CenterColumbusOhio43210
Richard Gumina, MD
St. Luke's University HospitalBethlehemPennsylvania18015
Neal Fitzpatrick, MD
AHN Saint Vincent HospitalEriePennsylvania16505
Orestis Pappas, MD
UPMC HamotEriePennsylvania16507
Robert Maholic, DO
UPMC HarrisburgHarrisburgPennsylvania17101
Torrey Schmidt, DO
The University of PennsylvaniaPhiladelphiaPennsylvania19104
Sameer Khandhar, MD
Thomas Jefferson UniversityPhiladelphiaPennsylvania19144
Mae West, MD
Allegheny Health Network Research InstitutePittsburghPennsylvania15212
Mithun Chakravarthy
UPMC Heart and Vascular InstitutePittsburghPennsylvania15213
Catalin Toma, MD
Wellspan York HospitalYorkPennsylvania17403
Paul Tolerico, MD
HCA TristarBrentwoodTennessee37027
Sam Horr, MD
UTMC KnoxvilleKnoxvilleTennessee37920
Chris Walker, MD
Ascension Saint Thomas HospitalNashvilleTennessee37203
Jimmy Kerrigan, MD
Parkland HospitalDallasTexas75235
Akram Sadeghi, MD
Texas Health Harris Methodist HospitalFort WorthTexas76104
John Hollingsworth, MD
Methodist Main HospitalSan AntonioTexas78229
Chandra Kunavarapu, MD
Jeffrey DellaVolpe, MD
Baylor Scott & White - TempleTempleTexas76508
Tasnim Lat, DO
Inova FairfaxFalls ChurchVirginia22042
Jonathan Keung, MD
Sentara Vascular SpecialistsNorfolkVirginia23507
David Dexter, MD
University of WashingtonSeattleWashington98195
Matthew Abad-Santos, MD
Providence Sacred HeartSpokaneWashington99204-
Charleston Area Medical CenterCharlestonWest Virginia25304
Shadi Abu-Halimah, MD
West Virginia University Ruby Memorial HospitalMorgantownWest Virginia26506
Sunil Sharma, MD
Aurora Saint Luke's Medical CenterMilwaukeeWisconsin53215
Khawaja Afzal Ammar, MD

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Brookwood Medical Center· Birmingham, ALUAB Division of Cardiovascular Disease· Birmingham, ALHuntington Memorial Hospital· Pasadena, CAUniversity of Colorado, Denver· Aurora, COYale University· New Haven, CTHCA FL Largo Medical Center· Largo, FL

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