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

Primary Purpose

Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClotTriever System
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Sponsored by
Inari Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome, Anticoagulation, Percutaneous Mechanical Thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of ColoradoRecruiting
  • Sarasota Memorial HospitalRecruiting
  • Community Healthcare SystemRecruiting
  • Holy Name Medical CenterRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • Saint Francis HospitalRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Allegheny General Health Research NetworkRecruiting
  • Sentara Norfolk General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interventional

Conservative Medical Management

Arm Description

Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).

Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Assessment of PTS Severity:
a. Assessment of PTS severity, as defined by the Villalta scale

Full Information

First Posted
January 6, 2023
Last Updated
April 6, 2023
Sponsor
Inari Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05701917
Brief Title
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Acronym
DEFIANCE
Official Title
DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inari Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome
Keywords
Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome, Anticoagulation, Percutaneous Mechanical Thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
Arm Title
Conservative Medical Management
Arm Type
Active Comparator
Arm Description
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
Intervention Type
Device
Intervention Name(s)
ClotTriever System
Intervention Description
Mechanical thrombectomy
Intervention Type
Drug
Intervention Name(s)
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Intervention Description
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Primary Outcome Measure Information:
Title
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Description
Occurrence of treatment failure or therapy escalation Assessment of PTS severity, as defined by the Villalta scale
Time Frame
180 Days (+-14 Days)
Secondary Outcome Measure Information:
Title
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Description
Vessel compressibility assessed by duplex ultrasound Pain as assessed by the NPRS An improvement of edema as assessed by leg calf circumference measurements
Time Frame
10 Days (+- 3 Days)
Title
Assessment of PTS Severity:
Description
a. Assessment of PTS severity, as defined by the Villalta scale
Time Frame
180 Days (+-14 Days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Wills
Phone
6027992920
Email
christine.wills@inarimedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Ottaviano
Phone
6096344571
Email
chris.ottaviano@inarimedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Abramowitz, MD
Organizational Affiliation
MedStar Health Research Institution
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xhorlina Marko, MD
Organizational Affiliation
Beaumont Dearborn Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Black, MD
Organizational Affiliation
St Thomas' Hospital (UK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lindquist, MD
Phone
303-315-5969
Email
JONATHAN.LINDQUIST@CUANSCHUTZ.EDU
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Lee, MD
Phone
941-917-9000
Email
justin.lee@radpartners.com
Facility Name
Community Healthcare System
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Stewart, MD
Phone
219-836-4473
Email
David.Stewart@comhs.org
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Rundback, MD
Phone
201-379-5614
Email
jrundback@aivsllp.com
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edvard Skripochnik, MD
Phone
877-426-5637
Email
es3879@cumc.columbia.edu
Facility Name
Saint Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tucker Harrison, DO
Phone
918-494-8500
Email
TJHarrison@saintfrancis.com
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Ford, MD
Phone
215-955-6000
Email
Robert.Ford@jefferson.edu
Facility Name
Allegheny General Health Research Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Shaikh, MD
Phone
412-362-8677
Email
Abdullah.Shaikh@AHN.org
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Dexter, MD
Phone
757-388-3000
Email
djdexte1@sentara.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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