DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Inari Medical
Study ID
NCT05701917
Status
Recruiting
Apply to this trial

Conditions

  • Deep Venous Thrombosis
  • Post-Thrombotic Syndrome
  • Venous Thromboembolism

Eligibility Criteria

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

Interventions

  • ClotTriever System — DEVICE
    Mechanical thrombectomy
  • Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. — DRUG
    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 an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.

Key Dates

Start date
Jan 6, 2023
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Interventional
    Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
  • Active Comparator: Conservative Medical Management
    Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).

Primary Outcome Measure

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: [ Time Frame: 180 Days (+-14 Days) ]

Central Contacts

Locations (48)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258
Venkataramanan Gangadharan, MD
Pima Heart and VascularTucsonArizona85704
Joseph Sabat, MD
UCI Medical CenterOrangeCalifornia92868
Anthony H Chau, MD
Vascular and Interventional Specialists of Orange CountyOrangeCalifornia92868
Theodore Bryan, MD
Huntington HealthPasadenaCalifornia91105
Theodore Teruya, MD
University Of ColoradoDenverColorado80045
Jonathan D Lindquist, MD
Yale UniversityNew HavenConnecticut06520
Hamid R Mojibian, MD
MedStar Health Research InstitutionWashington D.C.District of Columbia20010
Saher S Sabri, MD
Manatee Memorial HospitalBradentonFlorida34208-
Baptist Health Research InstituteJacksonvilleFlorida32207
Bharat Gummadi, MD
Lakeland Vascular InstituteLakelandFlorida33805-
HCA Florida Largo HospitalLargoFlorida33770
Jesse Klein, DO
Sarasota Memorial HospitalSarasotaFlorida34239
Juan C Camacho-Vasquez, MD
BayCare Health SystemTampaFlorida33607
Nicholas Turman, MD
Memorial Health University Medical CenterSavannahGeorgia31404-
Community Healthcare SystemMunsterIndiana46321-
St. Elizabeth EdgewoodEdgewoodKentucky41017-
University of MarylandBaltimoreMaryland21201
Khanjan Nagarsheth, MD
McLaren HealthcareBay CityMichigan48708
Nicolas Mouawad, MD
Henry Ford HealthDetroitMichigan48202
Scott Kaatz, MD
MyMichigan Medical CenterMidlandMichigan48670
Contantinos Constantinou, MD
University of MissouriColumbiaMissouri65212
Ambarish Bhat, MD
Saint Luke's Hospital of Kansas CityKansas CityMissouri64131-
St. Louis UniversitySt LouisMissouri63104
Keith Pereira, MD
University Medical Center of Southern NevadaLas VegasNevada89102
Ryan Rimer, MD
Cooper University HospitalCamdenNew Jersey08103
Laurel Hastings, MD
Holy Name Medical CenterTeaneckNew Jersey07666-
Northwell HealthBay ShoreNew York11706
Jonathan A Schor, MD
NYP-Brooklyn MethodistBrooklynNew York11215
Rajesh K Malik, MD
SUNY, The University at BuffaloBuffaloNew York14203-
Columbia University Irving Medical CenterNew YorkNew York10032
Edvard Skripochnik, MD
NYU Langone Medical CenterNew YorkNew York10016
Katherine Teter, MD
Mission HealthAshevilleNorth Carolina28801-
Mercy Health - The Heart InstituteCincinnatiOhio45211-
Cleveland ClinicClevelandOhio44195
Aravinda Nanjundappa, MD
Saint Francis HospitalTulsaOklahoma74136
Tucker J Harrison, DO
Allegheny St. Vincent HospitalEriePennsylvania16544
Orestis Pappas, MD
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Robert W Ford, MD
Allegheny General Health Research NetworkPittsburghPennsylvania15212
Abdullah A Shaikh, MD
Rhode Island HospitalProvidenceRhode Island02903
John Lee, MD
Prisma Health UpstateGreenvilleSouth Carolina29615-
Spartanburg Medical CenterSpartanburgSouth Carolina29303
Brian J Brown, MD
Lexington Medical CenterWest ColumbiaSouth Carolina29169-
Vanderbilt University Medical CenterNashvilleTennessee37232
Mark D Iafrati, MD
Clements University Hospital (UTSW)DallasTexas75390
Michael C Siah, MD
Sentara Norfolk General HospitalNorfolkVirginia23507
David J Dexter, MD
Providence Sacred Heart Med CenterSpokaneWashington99204-
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215-

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Honor Health· Scottsdale, AZPima Heart and Vascular· Tucson, AZUCI Medical Center· Orange, CAVascular and Interventional Specialists of Orange County· Orange, CAHuntington Health· Pasadena, CAUniversity Of Colorado· Denver, CO

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