ClotTriever vs Anticoagulation for Deep Vein Thrombosis

(DEFIANCE Trial)

Recruiting at 49 trial locations

Overseen By Paul Dalecke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inari Medical

Must be taking: Anticoagulants

Disqualifiers: Bilateral DVT, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 days

300 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 8 9}

Research Team

Steven Abramowitz, MD

Principal Investigator

MedStar Health Research Institution

Xhorlina Marko, MD

Principal Investigator

Henry Ford Health

Stephen Black

Principal Investigator

St Thomas' Hospital (UK)

Eligibility Criteria

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.

I am 18 years old or older.

Symptom onset within 12 weeks of enrollment in the study

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Conservative Medical Management Active Control 1 Intervention

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

Group II: Interventional Active Control 1 Intervention

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

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

Approved in European Union as ClotTriever Thrombectomy System for:

• Deep vein thrombosis (DVT)

Approved in United States as ClotTriever Thrombectomy System for:

• Deep vein thrombosis (DVT)
• Non-surgical removal of thrombi and emboli from blood vessels

Approved in Japan as ClotTriever Thrombectomy System for:

• Deep vein thrombosis (DVT)

Who Is Running the Clinical Trial?

Inari Medical

Lead Sponsor

Trials

18

Recruited

5,300+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Early and comprehensive removal of thrombus in deep vein thrombosis can lead to better outcomes, such as reduced risk of post-thrombotic syndrome and long-term symptoms.

The Inari ClotTriever system, approved by the FDA in 2017, offers a safe and effective method for clot removal without the high bleeding risks associated with traditional thrombolytic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ClotTriever system for mechanical thrombectomy of deep vein thrombosis. Chan, SM., Laage Gaupp, FM., Mojibian, H.[2023]

Thrombectomy using the ClotTriever system was successfully performed on all 14 patients with symptomatic deep venous occlusive disease, demonstrating excellent technical success and resolution of symptoms.

No major adverse events occurred during the procedure, indicating that the ClotTriever system is a safe option for treating deep vein thrombosis in the upper extremity and thorax.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous thrombectomy of upper extremity and thoracic central veins using Inari ClotTriever System: Experience in 14 patients. Sweeney, AM., Makary, MS., Greenberg, C., et al.[2023]

In a study of 250 patients with deep vein thrombosis (DVT), mechanical thrombectomy using the ClotTriever System achieved over 80% thrombus removal across all stages of DVT (acute, subacute, chronic), demonstrating its effectiveness.

The procedure was found to be safe, with only one serious adverse event reported (a fatal pulmonary embolism), and significant improvements in quality of life and clinical scores were observed at 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry. Abramowitz, SD., Kado, H., Schor, J., et al.[2023]

The ClotTriever system effectively removed large blood clots in all 12 patients treated for deep vein thrombosis (DVT) in a single session, achieving complete clot evacuation without the need for thrombolytics or repeat interventions.

All patients experienced symptom resolution before discharge, and there were no significant postoperative complications, such as anemia or kidney failure, indicating that this method is both safe and effective for managing acute DVT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical success and short-term outcomes after treatment of lower extremity deep vein thrombosis with the ClotTriever system: A preliminary experience. Benarroch-Gampel, J., Pujari, A., Aizpuru, M., et al.[2020]

The Inari ClotTriever device successfully restored venous flow in all 18 patients treated for extensive iliocaval or iliofemoral DVT, with no bleeding complications reported, indicating its safety and efficacy.

Most patients experienced mild postthrombotic syndrome or none at all after the procedure, and the median hospital stay was only 2 days, suggesting that ClotTriever may reduce recovery time compared to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring Venous Patency with the ClotTriever Following Deep Vein Thrombosis. Weissler, EH., Cox, MW., Commander, SJ., et al.[2022]

In a study involving 250 patients with lower extremity deep vein thrombosis (DVT), the ClotTriever System demonstrated high effectiveness in removing thrombus, achieving complete or near-complete removal in over 90% of acute cases and around 82% in chronic cases, all in a single session without the use of thrombolytics.

The study revealed that the chronicity of thrombus assessed by symptom duration often underestimated the actual chronicity observed post-thrombectomy, indicating that imaging is crucial for accurately determining thrombus characteristics and potential treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. Maldonado, TS., Dexter, DJ., Kado, H., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

ClotTriever system for mechanical thrombectomy of deep vein thrombosis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Percutaneous thrombectomy of upper extremity and thoracic central veins using Inari ClotTriever System: Experience in 14 patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Technical success and short-term outcomes after treatment of lower extremity deep vein thrombosis with the ClotTriever system: A preliminary experience. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Restoring Venous Patency with the ClotTriever Following Deep Vein Thrombosis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. [2022]