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

Inari Medical · NCT05701917

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
300
US sites recruiting
33
Study start
January 6, 2023
Record last updated
September 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ClotTriever System; Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Post-Thrombotic Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Bilateral iliofemoral DVT
  • Prior venous stent in the target venous segment
  • 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
  • Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time.
  • Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
  • Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
  • Severe allergy to iodinated contrast agents that cannot be mitigated
  • 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
  • Inability to provide therapeutic anticoagulation per Investigator discretion
  • Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
  • 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
  • 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)
  • Subject has previously completed or withdrawn from this study
  • Patient unwilling or unable to conduct the follow up visits per protocol

Recruiting US locations

  • Honor Health

    Scottsdale, AZ 85258

    Site contact: Venkataramanan Gangadharan, MD

  • Pima Heart and Vascular

    Tucson, AZ 85704

    Site contact: Joseph Sabat, MD

  • UCI Medical Center

    Orange, CA 92868

    Site contact: Anthony H Chau, MD

  • Vascular and Interventional Specialists of Orange County

    Orange, CA 92868

    Site contact: Theodore Bryan, MD

  • Huntington Health

    Pasadena, CA 91105

    Site contact: Theodore Teruya, MD

  • University Of Colorado

    Denver, CO 80045

    Site contact: Jonathan D Lindquist, MD

  • Yale University

    New Haven, CT 06520

    Site contact: Hamid R Mojibian, MD

  • MedStar Health Research Institution

    Washington D.C., DC 20010

    Site contact: Saher S Sabri, MD

  • Baptist Health Research Institute

    Jacksonville, FL 32207

    Site contact: Bharat Gummadi, MD

  • Sarasota Memorial Hospital

    Sarasota, FL 34239

    Site contact: Juan C Camacho-Vasquez, MD

  • BayCare Health System

    Tampa, FL 33607

    Site contact: Nicholas Turman, MD

  • University of Maryland

    Baltimore, MD 21201

    Site contact: Khanjan Nagarsheth, MD

  • McLaren Healthcare

    Bay City, MI 48708

    Site contact: Nicolas Mouawad, MD

  • Henry Ford Health

    Detroit, MI 48202

    Site contact: Scott Kaatz, MD

  • MyMichigan Medical Center

    Midland, MI 48670

    Site contact: Contantinos Constantinou, MD

  • University of Missouri

    Columbia, MO 65212

    Site contact: Ambarish Bhat, MD

  • St. Louis University

    St Louis, MO 63104

    Site contact: Keith Pereira, MD

  • University Medical Center of Southern Nevada

    Las Vegas, NV 89102

    Site contact: Ryan Rimer, MD

  • Cooper University Hospital

    Camden, NJ 08103

    Site contact: Laurel Hastings, MD

  • Northwell Health

    Bay Shore, NY 11706

    Site contact: Jonathan A Schor, MD

  • NYP-Brooklyn Methodist

    Brooklyn, NY 11215

    Site contact: Rajesh K Malik, MD

  • NYU Langone Medical Center

    New York, NY 10016

    Site contact: Katherine Teter, MD

  • Columbia University Irving Medical Center

    New York, NY 10032

    Site contact: Edvard Skripochnik, MD

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Aravinda Nanjundappa, MD

  • Saint Francis Hospital

    Tulsa, OK 74136

    Site contact: Tucker J Harrison, DO

  • Allegheny St. Vincent Hospital

    Erie, PA 16544

    Site contact: Orestis Pappas, MD

  • Thomas Jefferson University

    Philadelphia, PA 19107

    Site contact: Robert W Ford, MD

  • Allegheny General Health Research Network

    Pittsburgh, PA 15212

    Site contact: Abdullah A Shaikh, MD

  • Rhode Island Hospital

    Providence, RI 02903

    Site contact: John Lee, MD

  • Spartanburg Medical Center

    Spartanburg, SC 29303

    Site contact: Brian J Brown, MD

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Mark D Iafrati, MD

  • Clements University Hospital (UTSW)

    Dallas, TX 75390

    Site contact: Michael C Siah, MD

  • Sentara Norfolk General Hospital

    Norfolk, VA 23507

    Site contact: David J Dexter, MD

Study contacts (from the official record)

  • Mark Sung · 949-466-9458 · mark.sung@stryker.com
  • Sara Willis · sara.willis@stryker.com
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep… (NCT05701917) | Bored Studies