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ClotTriever vs Anticoagulation for Deep Vein Thrombosis (DEFIANCE Trial)
N/A
Recruiting
Led By Stephen Black, MD
Research Sponsored by Inari Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Significant symptoms, as defined by a Villalta score > 9
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days (+-14 days)
Awards & highlights
DEFIANCE Trial Summary
This trial compares an interventional strategy with anticoagulation therapy to treat iliofemoral DVT to see which is more effective in restoring vessel patency. Results will be collected over 6 months.
Who is the study for?
This trial is for adults over 18 with recent (within 12 weeks) symptoms of deep vein thrombosis in the leg, specifically in the iliofemoral region. Participants must have significant symptoms and be able to consent. Exclusions include severe anemia, bleeding disorders, kidney failure not on dialysis, bilateral DVTs, or other conditions that make anticoagulation or intervention risky.Check my eligibility
What is being tested?
The DEFIANCE trial compares two treatments for deep vein thrombosis: a new procedure using ClotTriever System versus standard blood thinners like Heparin or Warfarin. It's a randomized controlled study which means patients are put into treatment groups by chance to compare outcomes after six months.See study design
What are the potential side effects?
Potential side effects from the ClotTriever may include bleeding, pain at the site of intervention, and vessel damage. Standard anticoagulants can cause bleeding issues, allergic reactions (especially heparin), and possible kidney problems with certain drugs.
DEFIANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms are severe, with a Villalta score over 9.
Select...
I am 18 years old or older.
Select...
I have a blood clot in my upper leg or near my pelvis.
DEFIANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days (+-14 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days (+-14 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Assessment of PTS Severity
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following
DEFIANCE Trial Design
2Treatment groups
Active Control
Group I: Conservative Medical ManagementActive Control1 Intervention
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
Group II: InterventionalActive Control1 Intervention
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
Find a Location
Who is running the clinical trial?
Inari MedicalLead Sponsor
11 Previous Clinical Trials
4,061 Total Patients Enrolled
Stephen Black, MDPrincipal InvestigatorSt Thomas' Hospital (UK)
2 Previous Clinical Trials
272 Total Patients Enrolled
Steven Abramowitz, MDPrincipal InvestigatorMedStar Health Research Institution
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I recently had a procedure for a deep vein thrombosis.My limb is at risk due to severe circulation problems.Your blood pressure is very high and has not been controlled even after several measurements.My kidneys are severely impaired, but I am not on dialysis.I have blood clots in both legs' main veins.My hemoglobin is below 8.0, INR is above 1.7 without warfarin, or platelets are below 50,000 and cannot be corrected before joining.My symptoms are severe, with a Villalta score over 9.I cannot or do not want to follow the required visit schedule.I am 18 years old or older.You have had a stent placed in the specific vein being studied before.I have a congenital issue with my IVC or iliac veins.You have a filter in a large vein to catch blood clots.I have a serious lung clot and my doctor thinks treatment for leg vein clots isn't right for me now.You have a blood clot that is very large and extends into the main vein in your abdomen.You have a severe allergy or low platelet count caused by heparin.You have a strong allergy to iodinated contrast agents that can't be controlled.My doctor expects I have less than 6 months to live or I cannot walk.You have a condition that makes your blood clot easily and it cannot be controlled with medication during the study.I have a blood clot in my upper leg or near my pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Conservative Medical Management
- Group 2: Interventional
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies remaining in this trial for participants?
"Affirmative. Based on the information available through clinicaltrials.gov, this research project is currently recruiting patients, and it was first posted on January 6th of 2023 with a most recent update being published on the 18th of that same month. This trial requires 300 participants across two different sites to be enrolled in order for completion."
Answered by AI
What is the current enrollment count for this investigation?
"Affirmative. According to the information on clinicaltrials.gov, recruitment for this medical trial is ongoing and began on June 1st 2023; it was revised as recently as January 18th of 2022. The study requires 300 participants from two separate sites."
Answered by AI
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