Pulmonary Embolism Acute
Conditions
Keywords
pulmonary embolism, alphareturn
Brief summary
The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
Detailed description
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
Interventions
DEVICEAlphaReturn Blood Management System
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A potential subject will be included in the study if he/she meets all the following inclusion criteria: 1. Provision of signed and dated informed consent form. 2. Subject is 18 years of age and older. 3. Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. 4. Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). 5. Subject has a RV/LV ratio of 0.9 or higher. 6. Subject has a systolic blood pressure (SBP) of 90mmHg or higher. 7. Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure. 8. Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
Exclusion criteria
A potential subject will be excluded from the study if he/she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Success | Periprocedural | Successful autologous blood transfusion using the AlphaReturn Blood Management System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events (MAEs) | Through 48 hours post-procedure | The rate of MAEs within the first 48 hours after the index procedure. MAEs include device-related death, major bleeding, and device-related SAEs of clinical deterioration, pulmonary vascular injury, and cardiac injury. |
| Rate of Complications | Through 48 hours post-procedure | Rate of complications including device-related clinical deterioration, device-related cardiac injury, device-related pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure. |
| Rate of Device-Related SAEs | Through 30 days post-procedure | Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post procedure. |
| Rate of Symptomatic PE recurrence within 30 days | Through 30 days post-procedure | Symptomatic PE recurrence within 30 days. |
| Reduction in RV/LV Ratio | Through 48 hours post-procedure | Reduction in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA. |
| Thrombolytics Use | Through 48 hours post-procedure | Use of thrombolytics during or within 48 hours of the procedure. |
| Length of Stay in Intensive Care Unit | Through 30 days post-procedure | Length of stay in the Intensive Care Unit (ICU) within 30 days post-procedure. |
| Length of Stay in Hospital | Through 30 days post-procedure | Length of stay in the hospital within 30 days post-procedure. |
Countries
United States
Contacts
CONTACTElizabeth Manning
Outcome results
None listed