← Back to Search

Mechanical Aspiration Thrombectomy Device

AlphaVac MMA Device for Pulmonary Embolism (APEX-AV Trial)

Waitlist Available
Research Sponsored by Angiodynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours post-procedure
Awards & highlights

APEX-AV Trial Summary

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

Who is the study for?
This trial is for adults with acute intermediate-risk pulmonary embolism, stable heart rate and blood pressure, and a specific heart imaging ratio. They must have symptoms consistent with PE for no more than 14 days and be medically cleared for the procedure. Excluded are those who've had recent major surgery or trauma, used certain drugs recently, have severe organ issues or bleeding disorders, are pregnant/breastfeeding, or have other conditions that make them unsuitable.Check my eligibility
What is being tested?
The AlphaVac MMA F1885 PE device is being tested to see if it's safe and effective in removing blood clots from the lungs (pulmonary embolism) without surgery. Participants will undergo this non-surgical procedure where the device aspirates clots through a catheter inserted into the blood vessels.See study design
What are the potential side effects?
Possible side effects may include bleeding at the catheter insertion site, damage to blood vessels where the clot is removed, allergic reactions to contrast agents used during imaging procedures before and after treatment, irregular heartbeat due to irritation of heart tissue by equipment.

APEX-AV Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 hours post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 hours post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.
Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
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.
+3 more

APEX-AV Trial Design

1Treatment groups
Experimental Treatment
Group I: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PEExperimental Treatment1 Intervention
Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism
First Studied
Drug Approval Stage
How many patients have taken this drug
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Find a Location

Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
23 Previous Clinical Trials
2,243 Total Patients Enrolled

Media Library

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE (Mechanical Aspiration Thrombectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT05318092 — N/A
Pulmonary Embolism Research Study Groups: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Pulmonary Embolism Clinical Trial 2023: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE Highlights & Side Effects. Trial Name: NCT05318092 — N/A
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE (Mechanical Aspiration Thrombectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318092 — N/A
Pulmonary Embolism Patient Testimony for trial: Trial Name: NCT05318092 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollments for this research endeavor?

"The information on clinicaltrials.gov suggests that enrollment for this research is actively occurring, with the initial post date of August 1st 2022 and an latest update from 10th August 2022."

Answered by AI

How many participants will be recruited for this clinical research?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was originally posted on August 1st 2022, is currently recruiting for 122 patients at 2 different medical sites."

Answered by AI

What effects is this medical trial hoping to discern?

"Angiodynamics, Inc. has reported that the primary outcome to be monitored over a 48 hour period post-procedure is the alteration of RV/LV ratio between baseline and 48 hours assessed by CTA scan. Secondary outcomes being measured include rate of device related complications such as cardiac injury, pulmonary vascular damage, major bleeding and mortality within 48 hours; thrombolytic use within 48 hours; and symptomatic PE recurrence in 30 days following procedure."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Piedmont Heart Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

So maybe I can find out what caused it.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Piedmont Heart Institute: < 48 hours
~47 spots leftby May 2025