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

Key facts

Who runs it
Inari Medical
Where
Asheville, Baltimore, Bay City, Bay Shore, Bradenton, Brooklyn, Buffalo, Camden, Cincinnati, Cleveland, Columbia, Dallas, Denver, Detroit, Edgewood, Erie, Greenville, Jacksonville, Kansas City, Lakeland, Largo, Las Vegas, Midland, Milwaukee, Munster, Nashville, New Haven, New York, Norfolk, Orange, Pasadena, Philadelphia, Pittsburgh, Providence, Sarasota, Savannah, Scottsdale, Spartanburg, Spokane, St Louis, Tampa, Teaneck, Tucson, Tulsa, Washington D.C., and West Columbia, United StatesSee the 48 sitesAlso in 5 other countries, 16 sites
Trial code
Status
Recruiting
People taking part
300 people, planned
Started
6 Jan 2023
Expected to end
31 Jul 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ClotTriever System
  • Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Record updated
3 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • Age ≥ 18 years
  • Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination
  • Symptom onset within 12 weeks of enrollment in the study
  • Significant symptoms, as defined by a Villalta score > 9
  • Willing and able to provide informed consent

Who cannot take part

  • Prior venous stent in the target venous segment
  • Subject has previously completed or withdrawn from this study
  • Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time
  • Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
  • Severe allergy to iodinated contrast agents that cannot be mitigated
  • Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
  • 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., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
  • Hemoglobin < 8.0 g/dL, INR > 1.7 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment
  • Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis
  • Bilateral iliofemoral DVT
  • IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
  • IVC filter in place at the time of enrollment
  • Limb-threatening circulatory compromise (e.g., phlegmasia)
  • Clot in transit including IVC thrombus presenting as extension of >2cm into the IVC from the CIV
  • Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
  • Inability to provide therapeutic anticoagulation per Investigator discretion
  • Recently (< 30 days) had DVT interventional procedure
  • Subject is participating in another study that may interfere with this study
  • Life expectancy < 6 months or chronic non-ambulatory status
  • Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
  • Patient unwilling or unable to conduct the follow up visits per protocol

Where in United States

Also in 5 other countries, 16 sites

  • Mission HealthAsheville, United StatesContact: Mark SungNo longer taking part
  • University of MarylandBaltimore, United StatesContact: Khanjan Nagarsheth, MDTaking people
  • McLaren HealthcareBay City, United StatesContact: Nicolas Mouawad, MDTaking people
  • Northwell HealthBay Shore, United StatesContact: Jonathan A Schor, MDTaking people
  • Manatee Memorial HospitalBradenton, United StatesContact: Mark SungNo longer taking part
  • NYP-Brooklyn MethodistBrooklyn, United StatesContact: Rajesh K Malik, MDTaking people
  • SUNY, The University at BuffaloBuffalo, United StatesContact: Mark SungNo longer taking part
  • Cooper University HospitalCamden, United StatesContact: Laurel Hastings, MDTaking people
  • Mercy Health - The Heart InstituteCincinnati, United StatesContact: Mark SungNo longer taking part
  • Cleveland ClinicCleveland, United StatesContact: Aravinda Nanjundappa, MDTaking people
  • University of MissouriColumbia, United StatesContact: Ambarish Bhat, MDTaking people
  • Clements University Hospital (UTSW)Dallas, United StatesContact: Michael C Siah, MDTaking people
  • University of ColoradoDenver, United StatesContact: Jonathan D Lindquist, MDTaking people
  • Henry Ford HealthDetroit, United StatesContact: Scott Kaatz, MDTaking people
  • St. Elizabeth EdgewoodEdgewood, United StatesContact: Mark SungNo longer taking part
  • Allegheny St. Vincent HospitalErie, United StatesContact: Orestis Pappas, MDTaking people
  • Prisma Health-UpstateGreenville, United StatesContact: Mark SungNo longer taking part
  • Baptist Health Research InstituteJacksonville, United StatesContact: Bharat Gummadi, MDTaking people
  • Saint Luke's Hospital of Kansas CityKansas City, United StatesContact: Mark SungNo longer taking part
  • Lakeland Vascular InstituteLakeland, United StatesContact: Mark SungNo longer taking part
  • HCA Florida Largo HospitalLargo, United StatesContact: Mark SungNo longer taking part
  • University Medical Center of Southern NevadaLas Vegas, United StatesContact: Ryan Rimer, MDTaking people
  • MyMichigan Medical CenterMidland, United StatesContact: Contantinos Constantinou, MDTaking people
  • Aurora St. Luke's Medical CenterMilwaukee, United StatesContact: Mark SungNo longer taking part
  • Community Healthcare SystemMunster, United StatesContact: Mark SungNo longer taking part
  • Vanderbilt University Medical CenterNashville, United StatesContact: Mark D Iafrati, MDTaking people
  • Yale UniversityNew Haven, United StatesContact: Hamid R Mojibian, MDTaking people
  • Columbia University Irving Medical CenterNew York, United StatesContact: Edvard Skripochnik, MDTaking people
  • NYU Langone Medical CenterNew York, United StatesContact: Katherine Teter, MDTaking people
  • Sentara Norfolk General HospitalNorfolk, United StatesContact: David J Dexter, MDTaking people
  • UCI Medical CenterOrange, United StatesContact: Anthony H Chau, MDTaking people
  • Vascular and Interventional Specialists of Orange CountyOrange, United StatesContact: Theodore Bryan, MDTaking people
  • Huntington HealthPasadena, United StatesContact: Theodore Teruya, MDTaking people
  • Thomas Jefferson UniversityPhiladelphia, United StatesContact: Robert W Ford, MDTaking people
  • Allegheny General Health Research NetworkPittsburgh, United StatesContact: Abdullah A Shaikh, MDTaking people
  • Rhode Island HospitalProvidence, United StatesContact: John Lee, MDTaking people
  • Sarasota Memorial HospitalSarasota, United StatesContact: Juan C Camacho-Vasquez, MDTaking people
  • Memorial Health University Medical CenterSavannah, United StatesContact: Mark SungNo longer taking part
  • Honor HealthScottsdale, United StatesContact: Venkataramanan Gangadharan, MDTaking people
  • Spartanburg Medical CenterSpartanburg, United StatesContact: Brian J Brown, MDTaking people
  • Providence Sacred Heart Med CenterSpokane, United StatesContact: Mark SungNo longer taking part
  • St Louis UniversitySt Louis, United StatesContact: Keith Pereira, MDTaking people
  • Baycare Health SystemTampa, United StatesContact: Nicholas Turman, MDTaking people
  • Holy Name Medical CenterTeaneck, United StatesContact: Mark SungNo longer taking part
  • PIMA Heart and VascularTucson, United StatesContact: Joseph Sabat, MDTaking people
  • Saint Francis HospitalTulsa, United StatesContact: Tucker J Harrison, DOTaking people
  • MedStar Health Research InstitutionWashington D.C., United StatesContact: Saher S Sabri, MDTaking people
  • Lexington Medical CenterWest Columbia, United StatesContact: Mark SungNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • InterventionalExisting treatment, for comparison

    Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).

    Treatment: ClotTriever System

  • Conservative Medical ManagementExisting treatment, for comparison

    Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).

    Treatment: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
Record updated
3 November 2026