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.

← Back to Search

Device

ClotTriever vs Anticoagulation for Deep Vein Thrombosis (DEFIANCE Trial)

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

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 below

Select...

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)

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

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).

0 / 3Eligibility 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.