CompletedNot Applicable

Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

United States122 participantsStarted 2022-10-19

Plain-language summary

To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed and dated informed consent form. * 18 years of age and older. * Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. * Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). * Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher. * Systolic blood pressure (SBP) of 90 mmHg or higher * Heart rate of 130 beats per minute (BPM) or less prior to the procedure. * Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment. Exclusion Criteria: Excluded from the study if he/she meets any of the following exclusion criteria * May be pregnant as determined by a positive pregnancy test or who are breastfeeding. * Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants. * Has used thrombolytics (tPA) in the past 30 days of baseline CTA. * Has pulmonary hypertension with peak pulmonary artery pressure (PAP) \> 70 mmHg. * Fraction of inspired oxygen (FiO2) requirement \>40% or \>6 liters per minute (LPM) to keep oxygen saturations \>90% * Hematocrit \<28% within 6 hours of the index procedure. * Platelets count \< 100,000/µL. * Serum creatinine \>1.8 mg/dL. * International Normalized Ratio (INR) \> 3 * Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \> 15. * Presence of cancer requiring active chemother…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)

Timeframe: At 48 hours post-procedure

Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.

Timeframe: Within 48 hours post-procedure

Trial details

NCT IDNCT05318092

SponsorAngiodynamics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-04

Results submitted2024-05-01

View on ClinicalTrials.gov More Pulmonary Embolism trials