RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

Quick Facts

Study Start:2023-01-06
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Christine Wills
CONTACT
6027992920
christine.wills@inarimedical.com
Chris Ottaviano
CONTACT
6096344571
chris.ottaviano@inarimedical.com

Principal Investigator

Steven Abramowitz, MD
PRINCIPAL_INVESTIGATOR
MedStar Health Research Institution
Xhorlina Marko, MD
PRINCIPAL_INVESTIGATOR
Henry Ford Health
Stephen Black, MD
PRINCIPAL_INVESTIGATOR
St Thomas' Hospital (UK)

Study Locations (Sites)

Honor Health
Scottsdale, Arizona, 85258
United States
UCI Medical Center
Orange, California, 92868
United States
Vascular and Interventional Specialists of Orange County
Orange, California, 92868
United States
University Of Colorado
Denver, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06520
United States
MedStar Health Research Institution
Washington, District of Columbia, 20010
United States
Manatee Memorial Hospital
Bradenton, Florida, 34208
United States
Lakeland Vascular Institute
Lakeland, Florida, 33805
United States
HCA Florida Largo Hospital
Largo, Florida, 33770
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Community Healthcare System
Munster, Indiana, 46321
United States
St. Elizabeth Edgewood
Edgewood, Kentucky, 41017
United States
McLaren Healthcare
Bay City, Michigan, 48708
United States
University of Missouri
Columbia, Missouri, 65212
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64131
United States
St. Louis University
Saint Louis, Missouri, 63104
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
Northwell Health
Bay Shore, New York, 11706
United States
NYP-Brooklyn Methodist
Brooklyn, New York, 11215
United States
SUNY, The University at Buffalo
Buffalo, New York, 14203
United States
NYU Langone Medical Center
New York, New York, 10016
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Mission Health
Asheville, North Carolina, 28801
United States
Mercy Health - The Heart Institute
Cincinnati, Ohio, 45211
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Saint Francis Hospital
Tulsa, Oklahoma, 74136
United States
Allegheny St. Vincent Hospital
Erie, Pennsylvania, 16544
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Allegheny General Health Research Network
Pittsburgh, Pennsylvania, 15212
United States
Prisma Health Upstate
Greenville, South Carolina, 29615
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
Lexington Medical Center
West Columbia, South Carolina, 29169
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Clements University Hospital (UTSW)
Dallas, Texas, 75390
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Providence Sacred Heart Med Center
Spokane, Washington, 99204
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Inari Medical

  • Steven Abramowitz, MD, PRINCIPAL_INVESTIGATOR, MedStar Health Research Institution
  • Xhorlina Marko, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health
  • Stephen Black, MD, PRINCIPAL_INVESTIGATOR, St Thomas' Hospital (UK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-06
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2023-01-06
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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