Vertex Pulmonary Embolectomy System for Pulmonary Embolism (SPIRARE II Trial)

N/A

Recruiting

Research Sponsored by Neptune Medical

Eligibility Criteria Checklist

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

Must have

1. Age ≥ 18 years \< 80 years

3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 48 hours of the procedure

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new medical device called the Vertex Pulmonary Embolectomy System to see how safe and effective it is for treating patients with acute pulmonary embolism."

Who is the study for?

This trial is for adults aged 18 to 79 with symptoms of acute pulmonary embolism, confirmed by a CT scan showing blockage in major lung arteries. Participants must have stable blood pressure and agree to follow-up visits. It's not suitable for those outside the age range or who can't consent.

What is being tested?

The study is testing the Vertex Pulmonary Embolectomy System's safety and effectiveness in removing clots from lung arteries in patients with signs of a severe blockage that strains the heart.

What are the potential side effects?

Potential side effects may include risks associated with catheter-based procedures such as bleeding, infection at the insertion site, damage to blood vessels, irregular heartbeat, or more rarely stroke or heart attack.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 79 years old.

Select...

I have a confirmed blood clot in a major lung artery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 48 hours of the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 48 hours of the procedure

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

Major Adverse Events, a composite of

Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio

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: Vertex Pulmonary Embolectomy SystemExperimental Treatment1 Intervention

Patients presenting with clinical signs and symptoms of acute PE and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System

0 / 2Eligibility criteria met