ClotTriever vs Anticoagulation for Deep Vein Thrombosis

(DEFIANCE Trial)

Recruiting at 53 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for deep vein thrombosis (DVT), a blood clot in a large leg vein. One group will use the ClotTriever System, a device that clears the clot and keeps the vein open. The other group will use standard blood-thinning medication (anticoagulation medication). Researchers aim to determine which method works best over six months. Candidates may qualify if they have recently experienced DVT with noticeable symptoms affecting only one leg. As an unphased trial, this study offers participants the chance to contribute to medical knowledge and potentially benefit from innovative treatment options.

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 prior data suggests that the ClotTriever System is safe for treating deep vein thrombosis?

Research has shown that the ClotTriever System, a device for removing blood clots, has been tested in real-world situations. In one study with 500 patients, the treatment proved to be generally safe. Most participants tolerated it well, and serious side effects were rare. The ClotTriever System removes clots in the leg and is being compared to standard blood-thinning medications, which are already approved for treating blood clots.

For those considering joining the trial, it's important to know that both treatments have been used before and are known to be safe. The ClotTriever System has shown promising results in past studies, and blood thinners are a common treatment for blood clots. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ClotTriever System for treating deep vein thrombosis (DVT) because it offers a unique approach compared to standard anticoagulation therapies. Unlike anticoagulants, which work by thinning the blood to prevent clot growth, the ClotTriever System physically removes clots from the veins, potentially providing faster relief from symptoms. This mechanical approach could lead to quicker vessel clearance and reduce the long-term complications associated with DVT. Additionally, the ClotTriever System might offer a treatment option for patients who cannot tolerate traditional anticoagulation therapy.

What evidence suggests that this trial's treatments could be effective for deep vein thrombosis?

This trial will compare the ClotTriever System with standard anticoagulation therapy for treating deep vein thrombosis (DVT). Research has shown that the ClotTriever System effectively treats DVT, a condition where blood clots form in deep veins, usually in the legs. Studies from the ClotTriever Outcomes Registry demonstrated that the device successfully removes clots and helps keep veins open. Patients using ClotTriever reported fewer symptoms and a better quality of life over a year. The system is known for its safety and effectiveness, with excellent results in multiple studies. Unlike standard anticoagulation therapy, which uses medication to prevent new clots, ClotTriever physically removes existing clots. ^{2 6 7 8 9}

Who Is on the 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)

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

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 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?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. jscai.org jscai.org/article/S2772-9303(24)00014-0/fulltext

A CLOUT Registry Analysis We report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy.

2. clout.inarimedical.com clout.inarimedical.com/clout-2-year-outcomes

CLOUT 2 Year Outcomes Excellent long-term outcomes demonstrate the safety and effectiveness of wall-to-wall clot removal with the ClotTriever Thrombectomy System.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11308810/

A CLOUT Registry Analysis - PMC - PubMed Central - NIH One-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X22002566

Outcomes from the ClotTriever Outcomes Registry show ... This subanalysis from the all-comer ClotTriever Outcomes registry demonstrates that extracted thrombus in DVT may be more chronic than suggested by the ...

5. evtoday.com evtoday.com/articles/2023-mar/clinical-evidence-matters-how-clottriever-became-the-most-studied-thrombectomy-device-in-dvt-care

Clinical Evidence Matters: How ClotTriever Became the ... ClotTriever is the most studied thrombectomy system for the treatment of DVT, with excellent results replicated across multiple studies and published in peer- ...

6. inarimedical.com inarimedical.com/clout-registry

clout Evaluate real-world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity DVT with the ClotTriever system.

7. inarimedical.com inarimedical.com/clottriever-system

ClotTriever system for removing large clots ... - Inari Medical Six-month outcomes of mechanical thrombectomy for treating deep vein thrombosis: analysis from the 500-patient CLOUT registry. Cardiovasc Intervent Radiol. 2023 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03575364

NCT03575364 | ClotTriever Outcomes (CLOUT) Registry The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37105663/

Six-Month Deep Vein Thrombosis Outcomes by Chronicity Conclusions: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, ...