AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Pulmonary Embolism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pulmonary Embolism+1 MoreAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a new device is safe and effective at treating patients with a certain type of blood clot.

Eligible Conditions
  • Pulmonary Embolism

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: At 48 hours post-procedure

At 48 hours post-procedure
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure.
Day 30
Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.
Symptomatic PE recurrence within 30 days.
Hour 48
Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.
Use of thrombolytics within 48 hours of the procedure.

Trial Safety

Trial Design

1 Treatment Group

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
1 of 1

Experimental Treatment

122 Total Participants · 1 Treatment Group

Primary Treatment: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE · No Placebo Group · N/A

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Device
Experimental Group · 1 Intervention: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 48 hours post-procedure

Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
21 Previous Clinical Trials
2,141 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
A diagnosis of pulmonary embolism was made from computed tomography angiography (CTA).
You are medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
You have a heart rate of 130 BPM or less prior to the procedure.