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

Venous Thromboembolism Clinical Trial

— DEFIANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701917
• Other study ID #: 22-001
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: Inari Medical
• Contact: Christine Wills
• Phone: 6027992920
• Email: christine.wills[@]inarimedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will compare the clinical outcomes of patients treated with 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 symptomatic unilateral iliofemoral DVT. Up to 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• ClotTriever System
Mechanical thrombectomy

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Inari Medical

Countries where clinical trial is conducted

United States,  Finland,  Germany,  Switzerland,  United Kingdom, 

Outcome

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)