What side effects are associated with this type of intervention?

Mechanical thrombectomy, such as the ClotTriever System, is used to treat Post-Thrombotic Syndrome by removing clots and maintaining vessel patency. Common side effects include bleeding, vessel damage, and infection at the puncture site. Anticoagulation therapy, another common treatment, can lead to bleeding complications, while compression therapy may cause discomfort or skin irritation. These side effects should be discussed with a healthcare provider to determine the best treatment approach.

What prior FDA approvals exist?

The FDA has approved several treatments for Post-Thrombotic Syndrome (PTS), primarily focusing on anticoagulation therapies such as warfarin, rivaroxaban, and apixaban to prevent clot formation. Mechanical thrombectomy devices, like the ClotTriever System, are designed to physically remove clots and maintain vessel patency, offering an alternative to traditional anticoagulation. While specific FDA approvals for mechanical thrombectomy devices for PTS are limited, these devices are increasingly used in clinical practice for conditions like deep vein thrombosis (DVT) to prevent the progression to PTS.

What other types of research exist?

Promising novel alternatives to the ClotTriever System for treating Post-Thrombotic Syndrome patients in 2024 include: 1) The Penumbra System, which has demonstrated high recanalization rates and favorable outcomes in treating acute basilar artery occlusion and may be applicable to venous thrombosis. 2) Stent retrievers, which are commonly used in combination with other devices for mechanical thrombectomy and have shown effectiveness in various vascular conditions. 3) Endovascular stent-grafting, which may be feasible for patients who have had an embolic event and could help maintain vessel patency. These alternatives offer different mechanisms and approaches that could be beneficial for PTS patients.

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Device

ClotTriever vs Anticoagulation for Deep Vein Thrombosis (DEFIANCE Trial)

Q: What is the mechanism of action of this treatment?

The ClotTriever System, a mechanical thrombectomy device, is designed to remove clots and restore vessel patency in patients with Post-Thrombotic Syndrome (PTS). This system works by physically extracting thrombi from the veins, which helps to immediately restore blood flow and reduce venous hypertension, a key factor in PTS. By maintaining vessel patency, the ClotTriever System can prevent the recurrence of clots and reduce the risk of chronic pain, swelling, and ulceration associated with PTS. This is crucial for PTS patients as it directly addresses the underlying cause of their symptoms and can significantly improve their quality of life. Other common treatments for PTS include anticoagulation therapy to prevent further clot formation and compression therapy to manage symptoms, but these do not remove existing clots as effectively as mechanical thrombectomy.

N/A

Recruiting

Led By Steven Abramowitz, 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

Must not have

Recently (< 30 days) had DVT interventional procedure

Limb-threatening circulatory compromise (e.g., phlegmasia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days (+-14 days)

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My symptoms are severe, with a Villalta score over 9.

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I am 18 years old or older.

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I have a blood clot in my upper leg or near my pelvis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I recently had a procedure for a deep vein thrombosis.

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My limb is at risk due to severe circulation problems.

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My kidneys are severely impaired, but I am not on dialysis.

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I have blood clots in both legs' main veins.

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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.

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I cannot or do not want to follow the required visit schedule.

Select...

I have a congenital issue with my IVC or iliac veins.

Select...

My doctor expects I have less than 6 months to live or I cannot walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days (+-14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days (+-14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days (+-14 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following

Secondary study objectives

Assessment of PTS Severity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The ClotTriever System, a mechanical thrombectomy device, is designed to remove clots and restore vessel patency in patients with Post-Thrombotic Syndrome (PTS). This system works by physically extracting thrombi from the veins, which helps to immediately restore blood flow and reduce venous hypertension, a key factor in PTS. By maintaining vessel patency, the ClotTriever System can prevent the recurrence of clots and reduce the risk of chronic pain, swelling, and ulceration associated with PTS. This is crucial for PTS patients as it directly addresses the underlying cause of their symptoms and can significantly improve their quality of life. Other common treatments for PTS include anticoagulation therapy to prevent further clot formation and compression therapy to manage symptoms, but these do not remove existing clots as effectively as mechanical thrombectomy.

Management of Phlegmasia Cerulea Dolens with Percutaneous Mechanical Thrombectomy.