Recruiting

ClotTriever vs. Anticoagulation

Sponsor:

Inari Medical

Code:

NCT05701917

Conditions

Venous Thromboembolism

Deep Venous Thrombosis

Post-Thrombotic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ClotTriever System

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

Study Details

Brief summary:

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.

Conditions

Venous Thromboembolism

Deep Venous Thrombosis

Post-Thrombotic Syndrome

Study ID

NCT05701917

Start date

Jan 6, 2023

Status verified date

Aug, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

ClotTriever System

Mechanical thrombectomy

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: [ Time Frame: 180 Days (+-14 Days) ]

Central Contacts and Locations

Central contacts

Mark Sung

949-466-9458mark.sung@stryker.com

Sara Willis

sara.willis@stryker.com

Locations

Honor Health

Recruiting

Scottsdale, Arizona, United States, 85258

Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85704

UCI Medical Center

Recruiting

Orange, California, United States, 92868

Vascular and Interventional Specialists of Orange County

Recruiting

Orange, California, United States, 92868

Huntington Health

Recruiting

Pasadena, California, United States, 91105

University Of Colorado

Recruiting

Denver, Colorado, United States, 80045

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

MedStar Health Research Institution

Recruiting

Washington D.C., District of Columbia, United States, 20010

Baptist Health Research Institute

Recruiting

Jacksonville, Florida, United States, 32207

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

BayCare Health System

Recruiting

Tampa, Florida, United States, 33607

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

McLaren Healthcare

Recruiting

Bay City, Michigan, United States, 48708

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

MyMichigan Medical Center

Recruiting

Midland, Michigan, United States, 48670

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

St. Louis University

Recruiting

St Louis, Missouri, United States, 63104

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Northwell Health

Recruiting

Bay Shore, New York, United States, 11706

NYP-Brooklyn Methodist

Recruiting

Brooklyn, New York, United States, 11215

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Saint Francis Hospital

Recruiting

Tulsa, Oklahoma, United States, 74136

Allegheny St. Vincent Hospital

Recruiting

Erie, Pennsylvania, United States, 16544

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Allegheny General Health Research Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Clements University Hospital (UTSW)

Recruiting

Dallas, Texas, United States, 75390

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

Inari Medical

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Venous Thromboembolism
  • Deep Venous Thrombosis
  • Post-Thrombotic Syndrome
  • Anticoagulation
  • Percutaneous Mechanical Thrombectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Inari Medical on 2026-08-18.