300 Participants Needed

ClotTriever vs Anticoagulation for Deep Vein Thrombosis

(DEFIANCE Trial)

Recruiting at 48 trial locations
CW
CO
PD
Overseen ByPaul Dalecke
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Inari Medical
Must be taking: Anticoagulants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effectiveness of the ClotTriever System, which removes blood clots from veins, to standard blood-thinning medication in patients with symptomatic blood clots in one leg. The ClotTriever System, developed by Inari Medical, is a mechanical device used to treat deep vein thrombosis (DVT) by removing blood clots from veins.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is the ClotTriever System safe for treating deep vein thrombosis?

The ClotTriever System has been studied for its safety in treating deep vein thrombosis (DVT), with research indicating it can be used without the need for additional medications that increase bleeding risk. Studies have shown it to be generally safe for patients, although some procedures may not completely remove all clots.12345

How is the ClotTriever treatment different from other treatments for deep vein thrombosis?

The ClotTriever System is a mechanical treatment for deep vein thrombosis (DVT) that removes blood clots without the need for additional medications that thin the blood, which can reduce the risk of bleeding compared to traditional treatments that use drugs to dissolve clots.23467

What data supports the effectiveness of the ClotTriever System treatment for deep vein thrombosis?

Research shows that the ClotTriever System is effective in removing blood clots in deep vein thrombosis (DVT) without the high bleeding risk associated with other methods. Studies, including the CLOUT registry, have reported positive outcomes in patients treated with this system, indicating its safety and effectiveness for DVT.23489

Who Is on the Research Team?

Steven David Abramowitz, MD| Vascular ...

Steven Abramowitz, MD

Principal Investigator

MedStar Health Research Institution

XM

Xhorlina Marko, MD

Principal Investigator

Henry Ford Health

SB

Stephen Black

Principal Investigator

St Thomas' Hospital (UK)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My symptoms are severe, with a Villalta score over 9.
Symptom onset within 12 weeks of enrollment in the study
Willing and able to provide informed consent
See 1 more

Exclusion Criteria

Subject has previously completed or withdrawn from this study
I recently had a procedure for a deep vein thrombosis.
My limb is at risk due to severe circulation problems.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the ClotTriever System intervention or conservative medical management with anticoagulation therapy

10 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PTS severity and clinical outcomes

6 months
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ClotTriever System
  • Commercially available/market approved anticoagulation medication
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Conservative Medical ManagementActive Control1 Intervention
Group II: InterventionalActive Control1 Intervention

ClotTriever System is already approved in European Union, United States, Japan for the following indications:

🇪🇺
Approved in European Union as ClotTriever Thrombectomy System for:
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Approved in United States as ClotTriever Thrombectomy System for:
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Approved in Japan as ClotTriever Thrombectomy System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Inari Medical

Lead Sponsor

Trials
18
Recruited
5,300+

Published Research Related to This Trial

The BOLD catheter, used in the ClotTriever System for treating deep vein thrombosis (DVT), demonstrated high procedural success with a 90.9% rate of achieving at least a 75% reduction in venous occlusion across treated segments, with a median reduction rate of 100%.
The study, which reviewed 11 cases, reported no intraprocedural adverse events or device malfunctions, indicating that the BOLD catheter is safe for use in patients with symptomatic proximal lower extremity DVT.
Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity.De Marco Garcia, LP.[2023]
In a study of 250 patients with lower extremity deep vein thrombosis (DVT), the ClotTriever System achieved complete or near-complete thrombus removal in 86% of cases, demonstrating its effectiveness across various thrombus chronicities.
The procedure was safe, with only one device-related serious adverse event reported within 30 days, and significant improvements in symptoms and quality of life were observed at 6 months post-treatment.
Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry.Dexter, DJ., Kado, H., Schor, J., et al.[2022]
In a study of 96 patients with acute iliofemoral deep vein thrombosis (DVT), the ClotTriever thrombectomy system achieved a high efficacy rate, with 97% of patients experiencing at least 75% thrombus removal, demonstrating its effectiveness in managing this condition.
The procedure was found to be safe, with only 2% of patients experiencing a symptomatic pulmonary embolism and no major bleeding or device-related complications reported, indicating a favorable safety profile for the ClotTriever system.
Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis.Jolly, MA., Lockhart, MM., Shah, D., et al.[2023]

Citations

Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity. [2023]
Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry. [2022]
Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis. [2023]
ClotTriever system for mechanical thrombectomy of deep vein thrombosis. [2023]
Percutaneous thrombectomy of upper extremity and thoracic central veins using Inari ClotTriever System: Experience in 14 patients. [2023]
Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry. [2023]
Technical success and short-term outcomes after treatment of lower extremity deep vein thrombosis with the ClotTriever system: A preliminary experience. [2020]
Restoring Venous Patency with the ClotTriever Following Deep Vein Thrombosis. [2022]
Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. [2022]
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