Acute Pulmonary Embolism Treatment with AlphaVac and AlphaReturn Systems
This study is testing the safety and effectiveness of the AlphaReturn Blood Management System when used with the AlphaVac Multipurpose Mechanical Aspiration System. These devices are used to treat acute pulmonary embolism (blood clots in the lungs). You may be able to join if you are 18 or older and have symptoms of an acute intermediate-risk pulmonary embolism that started within the last 14 days. The study will look at how often device-related problems occur within 30 days after the procedure and how successful the procedure is. The current recruitment status is unclear, and the study plans to enroll 39 participants.
- Study design
- This is a single-arm study, meaning all participants receive the same treatment. It is an investigational device study evaluating safety and effectiveness.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for device-related adverse events through 30 days post-procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness
At a glance
Conditions
NCT07280247
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Baylor Heart Hospital Plano
Plano, Texasstudy coordinator listed
Recruiting
CentraCare Heart and Vascular Center
Saint Cloud, Minnesotastudy coordinator listed
Recruiting
Jacobi Medical Center
The Bronx, New Yorkstudy coordinator listed
Recruiting
Kettering Health
Kettering, Ohiostudy coordinator listed
Recruiting
Methodist Healthcare
San Antonio, Texasstudy coordinator listed
Recruiting
University at Buffalo
Buffalo, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Rate of Device-Related Adverse Events (AEs)Through 30 days post-procedure
The number and proportion of subjects who experienced at least one device-related adverse event. This will be summarized, and the 95% confidence interval of the proportion will be presented. The incidence of device-related adverse events by type and seriousness through 30 days will also be summarized.
- Rate of Technical SuccessPeriprocedural
Successful autologous blood transfusion using the AlphaReturn Blood Management System