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Mechanical Aspiration Thrombectomy Device
AlphaVac MMA Device for Pulmonary Embolism (APEX-AV Trial)
N/A
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours post-procedure
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 48 hours post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 hours post-procedure
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 moreTrial 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
2022
N/A
~130
Find a Location
Who is running the clinical trial?
Angiodynamics, Inc.Lead Sponsor
23 Previous Clinical Trials
2,243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received clot-dissolving medication (tPA) within the last 30 days before the screening.You need a high amount of oxygen to keep your blood oxygen levels normal.Your blood does not have enough red blood cells.Your blood clotting test shows that it takes too long for your blood to clot.Your platelet count is less than 100,000 per microliter.You cannot take heparin or other blood thinners for medical reasons.You need medication to keep your blood pressure above a certain level after receiving fluids.You have a condition called left bundle branch block.You have a device implanted in your heart's right ventricle or atrium.You have had a severe allergic reaction to the contrast dye used in medical imaging, and it cannot be prevented with medication beforehand.You need a machine to help you breathe, like ECMO.You have had a serious injury in the past 14 days with a score higher than 15 on the Injury Severity Scale.You have a known condition that makes you bleed easily or affects your blood's ability to clot.You have symptoms of a specific type of lung blood clot that started within the past two weeks.You have been diagnosed with a pulmonary embolism using a special type of x-ray called computed tomography angiography (CTA).The ratio of the right ventricle to the left ventricle in the heart is 0.9 or higher.Your systolic blood pressure is 90mmHg or higher.Your heart beats at a rate of 130 beats per minute or less before the procedure.You are not expected to live more than 90 days.You have high blood pressure in the arteries of your lungs.You have a history of serious heart or lung conditions, or a specific blood disorder called Heparin-induced thrombocytopenia (HIT).Your blood creatinine level is higher than 1.8 mg/dL.You currently have cancer that needs to be treated with chemotherapy.Tests or images show that the person is not a good fit for this procedure.
Research Study Groups:
This trial has the following groups:- Group 1: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pulmonary Embolism Patient Testimony for trial: Trial Name: NCT05318092 — N/A
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