What side effects are associated with this type of intervention?

Mechanical thrombectomy, a treatment for pulmonary embolism, involves the physical removal of the clot using specialized devices like the Viper Catheter System. Common side effects of mechanical thrombectomy include bleeding, vascular injury, and potential complications related to the catheter insertion site, such as infection or hematoma. Other treatments for PE, such as anticoagulants (e.g., heparin, warfarin, DOACs), can cause bleeding complications, including gastrointestinal bleeding and hemorrhagic stroke. Thrombolytic therapy, which involves clot-dissolving medications, also carries a significant risk of major bleeding.

What prior FDA approvals exist?

The FDA has approved several mechanical thrombectomy devices for the treatment of acute pulmonary embolism (PE). These devices are designed to physically remove clots from the pulmonary arteries. Examples include the FlowTriever System by Inari Medical and the Indigo Aspiration System by Penumbra. These devices are used in cases where anticoagulation therapy alone is insufficient or contraindicated. Additionally, catheter-directed thrombolysis using drugs like tissue plasminogen activator (tPA) has been approved for PE treatment, providing a pharmacomechanical approach to clot dissolution.

What other types of research exist?

Promising alternatives to the Viper Catheter System for treating pulmonary embolism include: 1) The FlowTriever System, which has shown efficacy in large-bore mechanical thrombectomy for PE. 2) The Indigo Aspiration System, which uses continuous aspiration to remove thrombus. 3) The Penumbra System, another mechanical thrombectomy device that has been effective in clot removal. Additionally, advancements in catheter-directed thrombolysis (CDT) and combination therapies involving low-dose thrombolytics with mechanical thrombectomy are also being explored as effective treatments for PE.

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Thrombectomy Device

Viper Catheter System for Pulmonary Embolism (ENGULF Trial)

N/A

Recruiting

Led By Julie Bulman, MD

Research Sponsored by Endovascular Engineering

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours following the procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and feasibility of a new device called the Viper Catheter System, which is designed to remove blood clots from the lungs of patients with serious but not fully blocking clots. The device works by being inserted into the blood vessels and physically extracting the clots to help restore normal blood flow.

Who is the study for?

This trial is for adults aged 22 to 90 with acute submassive pulmonary embolism, stable blood pressure and heart rate, and evidence of a blockage in the lung arteries. They must be able to consent and have not used certain blood thinners recently. Excluded are those with severe heart issues, recent major surgery or trauma, extreme obesity, or conditions affecting life expectancy.

What is being tested?

The study tests the Viper Catheter System's safety and feasibility for removing clots from lung arteries in patients with a type of lung blockage called acute submassive pulmonary embolism. It's an initial evaluation using this novel device on eligible participants.

What are the potential side effects?

Potential side effects may include bleeding complications, allergic reactions to device materials or contrast agents used during the procedure, damage to blood vessels where the catheter is inserted, irregular heartbeat risks due to catheter navigation through heart chambers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours following the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours following the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours following the procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Performance Objective

Primary Safety Objective

Secondary study objectives

Secondary Performance Objective

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational DeviceExperimental Treatment1 Intervention

The study design includes two cohorts: a Pre-Pivotal Cohort of up to 50 subjects (25 Feasibility and up to 25 Roll-Ins), and a Pivotal Cohort enrolling up to 131 subjects, to yield 100 evaluable subjects at 48 hours post procedure.

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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

Mechanical thrombectomy, such as the Viper Catheter System, physically removes blood clots from the pulmonary arteries, rapidly restoring blood flow and reducing right ventricular strain. This is crucial for pulmonary embolism patients as it improves oxygenation and reduces the risk of severe complications. Other treatments include anticoagulants, which prevent further clot formation, and thrombolytics, which actively dissolve clots. These treatments aim to prevent recurrent PE, chronic thromboembolic pulmonary hypertension, and death.