Acute Pulmonary Embolism (PE), Pulmonary Embolism
Conditions
Brief summary
To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.
Interventions
DEVICEAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 for the treatment of acute pulmonary embolism
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
* Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery * RV/LV diameter ratio ≥ 1.0 assessed by CTPA * Serum troponin levels above upper limit of normal as per hospital policy * ≥ 18 years of age * At least one of the following: 1. Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis 2. Systolic blood pressure ≤ 110mmHg for at least 15 minutes 3. Respiratory rate \> 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while breathing room air 4. Known history of heart failure * Willing and able to provide written informed consent prior to receiving study specific procedures.
Exclusion criteria
* A contraindication to therapeutic anticoagulation * Any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer) * Known serious, uncontrolled sensitivity to radiographic agents * Cardiac arrest within last 14 days without documented evidence of recovery of conscious level to Glasgow Coma Scale \>12 * Indication for ECMO * Pregnant or breastfeeding * Participation in another investigational drug or device study that study may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies. * Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study. * History of congenital or acquired bleeding disorder predisposing to hemorrhagic state * Platelet count \< 100,000/μL * Any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention) * A known clot in transit * IVC filter * A do not resuscitate limitation at inclusion in the study * Deprived of liberty or under court protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in RV/LV ratio | 48 hours | Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA) |
| Incidence of Adverse Events [Safety and Tolerability] | 12 months | The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in clot burden | 48 hours | • Reduction in clot burden (measured by refined Modified Miller Index score) between baseline and 48 hours post-procedure assessed by paired CTPA |
| Use of thrombolytics | 48 hours | Use of thrombolytics within 48 hours of the index procedure |
| Change in Biomarkers | 48 hours | Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure |
| Composite Major Adverse Events | 7 days | * Composite Major Adverse Events within 7 days of the index procedure 1\) PE-related death/deterioration: * Death * Cardiac Arrest * Institution of new vasopressors * ECMO * Mechanical ventilation 2\) Device-related death/deterioration: * Death * BARC 3a/3b/3c/-5 Major Bleeding * Clinical Deterioration * Pulmonary Vascular Injury * Peripheral Vascular Injury * Cardiac Injury * Stroke |
| Individual Major Adverse Events | 7 days | Individual Major Adverse Events within 7 days of the index procedure * PE-related Death * PE-related Cardiac Arrest * PE-related institution of new vasopressors * PE-related ECMO * mechanical ventilation * device-related Death * device-related Major Bleeding * device-related Clinical Deterioration * device-related Pulmonary Vascular Injury * device-related Peripheral Vascular Injury * device-related Cardiac Injury * device-related Stroke |
| Days in ITU | 7 days | Days in ITU post-index procedure admission |
| Device-related Serious Adverse Events | 30 days | Device-related Serious Adverse Events (SAEs) within 30 days of the index procedure |
| Days In-patient | 30 days | Number of days in-patient on index procedure admission |
| Hospital readmission | 30 days | Hospital readmission rate through 30 days |
| Symptom burden exercise test | 30 days | 6 minute walking test (MWT) at 30 days post-procedure |
| Symptom burden classification | 30 Days | New York Heart Association (NYHA) classification at 30 Days post-procedure |
| Functional outcome review | 30 Days | PROMs at 30 Days post-procedure: * PROMIS Scale v1.2 - Global Health \- PEmb-QoL * Post-VTE Functional Status Scale * PROMIS Short Form v2.0 - Pain Intensity 3a * PROMIS Short Form v1.0 - Dyspnea Severity 10a * PHQ-9 * GAD-7 |
| Symptomatic PE recurrence | 30 days | Symptomatic PE recurrence at 30 days post-procedure |
| PE-related readmission | 12 months | \- PE-related hospital readmission rate through 12 months post-procedure |
| CTEPH Diagnosis | 12 months | Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at 12 months post-procedure |
| All-cause mortality | 30 days | All-cause mortality within 30 days of the index procedure |
| PE-related mortality | 30 days | • PE-related mortality within 30 days of the index procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac MRI | 12 months | • Cardiac MRI at 12-months post-procedure (for up to 100 patients) to assess: * RA/RV dimension and function * Signs of RV fibrosis * Pulmonary parenchymal function and abnormalities * Pulmonary vascular structure * Tricuspid regurgitation severity * Ventricular Septal motion characteristics |
| Peak Oxygen Consumption | 12 months | • Peak Oxygen consumption (for up to 100 patients): PVO2 measured during cardiopulmonary exercise test at 12 months post-procedure |
Countries
Poland
Contacts
Primary ContactMitch Vanderpoll
Outcome results
None listed