Venous Thromboembolism Clinical Trial
— DEFIANCEOfficial title:
DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | October 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital | Helsinki | |
Germany | Klinikum Hochsauerland GmbH | Arnsberg | Nordrhein-Westfalen |
Germany | Universitätsklinikum Augsburg | Augsburg | |
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt | Hessen |
Germany | Universität Leipzig | Leipzig | Sachsen |
Germany | Universitätsklinikum Tübingen | Tübingen | Baden-Würtemberg |
Switzerland | Inselspital, Universitätsspital Bern | Bern | |
United Kingdom | GSST London/St Thomas | London | |
United Kingdom | Oxford - John Radcliffe | Oxford | |
United States | Mission Health | Asheville | North Carolina |
United States | McLaren Healthcare | Bay City | Michigan |
United States | Northwell Health | Bay Shore | New York |
United States | Manatee Memorial Hospital | Bradenton | Florida |
United States | NYP-Brooklyn Methodist | Brooklyn | New York |
United States | SUNY, The University at Buffalo | Buffalo | New York |
United States | Mercy Health - The Heart Institute | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Missouri | Columbia | Missouri |
United States | Clements University Hospital (UTSW) | Dallas | Texas |
United States | University Of Colorado | Denver | Colorado |
United States | St. Elizabeth Edgewood | Edgewood | Kentucky |
United States | Allegheny St. Vincent Hospital | Erie | Pennsylvania |
United States | Prisma Health Upstate | Greenville | South Carolina |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Lakeland Vascular Institute | Lakeland | Florida |
United States | HCA Florida Largo Hospital | Largo | Florida |
United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Community Healthcare System | Munster | Indiana |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | Columbia University Irving Medical Center | New York | New York |
United States | NYU Langone Medical Center | New York | New York |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | UCI Medical Center | Orange | California |
United States | Vascular and Interventional Specialists of Orange County | Orange | California |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Allegheny General Health Research Network | Pittsburgh | Pennsylvania |
United States | St. Louis University | Saint Louis | Missouri |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | Honor Health | Scottsdale | Arizona |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Providence Sacred Heart Med Center | Spokane | Washington |
United States | Holy Name Medical Center | Teaneck | New Jersey |
United States | Saint Francis Hospital | Tulsa | Oklahoma |
United States | MedStar Health Research Institution | Washington | District of Columbia |
United States | Lexington Medical Center | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Inari Medical |
United States, Finland, Germany, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: | Occurrence of treatment failure or therapy escalation
Assessment of PTS severity, as defined by the Villalta scale |
180 Days (+-14 Days) | |
Secondary | Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: | Vessel compressibility assessed by duplex ultrasound
Pain as assessed by the NPRS An improvement of edema as assessed by leg calf circumference measurements |
10 Days (+- 3 Days) | |
Secondary | Assessment of PTS Severity: | a. Assessment of PTS severity, as defined by the Villalta scale | 180 Days (+-14 Days) |
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