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AlphaVac MMA Device for Pulmonary Embolism (APEX-AV Trial)
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.
APEX-AV Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APEX-AV Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Piedmont Heart Institute: < 48 hours
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