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

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ClinicalTrials.gov Identifier: NCT05701917
Recruitment Status : Recruiting
First Posted : January 27, 2023
Last Update Posted : December 27, 2023
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Venous Thrombosis Post-Thrombotic Syndrome Device: ClotTriever System Drug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. Not Applicable

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
Actual Study Start Date : January 6, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Interventional
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
 Device: ClotTriever System
Mechanical thrombectomy
Active Comparator: Conservative Medical Management
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: [ Time Frame: 180 Days (+-14 Days) ]
    1. Occurrence of treatment failure or therapy escalation
    2. Assessment of PTS severity, as defined by the Villalta scale


Secondary Outcome Measures :
  1. Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: [ Time Frame: 10 Days (+- 3 Days) ]
    1. Vessel compressibility assessed by duplex ultrasound
    2. Pain as assessed by the NPRS
    3. An improvement of edema as assessed by leg calf circumference measurements

  2. Assessment of PTS Severity: [ Time Frame: 180 Days (+-14 Days) ]
    a. Assessment of PTS severity, as defined by the Villalta scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05701917


Contacts
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Contact: Christine Wills 6027992920 christine.wills@inarimedical.com
Contact: Chris Ottaviano 6096344571 chris.ottaviano@inarimedical.com

Locations
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Sponsors and Collaborators
Inari Medical
Investigators
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Principal Investigator: Steven Abramowitz, MD MedStar Health Research Institution
Principal Investigator: Xhorlina Marko, MD Beaumont Dearborn Hospital
Principal Investigator: Stephen Black, MD St Thomas' Hospital (UK)
More Information
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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT05701917    
Other Study ID Numbers: 22-001
First Posted: January 27, 2023    Key Record Dates
Last Update Posted: December 27, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Inari Medical:
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
Anticoagulation
Percutaneous Mechanical Thrombectomy
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Heparin
 Calcium heparin
Rivaroxaban
Apixaban
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors