Symphony Thrombectomy for Pulmonary Embolism

N/A

Recruiting

Research Sponsored by Imperative Care, Inc.

Eligibility Criteria Checklist

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

Must have

Clinical signs and symptoms consistent with acute PE.

Subject is between 18 and 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial studied using a device to treat PE and found it to be safe and effective.

Who is the study for?

This trial is for adults aged 18-80 with recent pulmonary embolism (PE), confirmed by CTA, who have symptoms of PE and a stable blood pressure and heart rate. Participants must have an enlarged right ventricle but be in a stable condition to give consent and follow the study protocol.

What is being tested?

The Symphony Thrombectomy System is being tested for safety and effectiveness in removing blood clots from the lungs (pulmonary embolism). This device aims to improve cardiovascular health by treating these potentially life-threatening clots.

What are the potential side effects?

While specific side effects are not listed, thrombectomy procedures can generally cause bleeding, bruising at the catheter site, infection risk, or rare complications like injury to the blood vessels.

Eligibility Criteria

Inclusion Criteria

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

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I am showing signs of a possible pulmonary embolism.

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I am between 18 and 80 years old.

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My blood pressure is at least 90 mmHg and I have a heart condition where my right ventricle is enlarged.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

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

Treatment Details

Study Objectives

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

Primary study objectives

Mean reduction of RV/LV ratio

Rate of major adverse events

Secondary study objectives

Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury

Rates of PE related mortality, all-cause mortality, device-related SAEs and symptomatic PE recurrence