Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Launched by ANGIODYNAMICS, INC. · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method for a serious condition called acute pulmonary embolism (PE), which occurs when a blood clot blocks blood vessels in the lungs. The study will evaluate how effective and safe a device called the AlphaVac Multipurpose Mechanical Aspiration System is for removing these clots. Researchers want to find out how well this treatment works in the long term, helping patients recover and improve their quality of life.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with acute PE within the last 14 days, confirmed by a special imaging test. They should also have certain symptoms, like a rapid heartbeat or low blood pressure. However, there are some exclusions, such as having a serious illness with a short life expectancy or being pregnant. Participants will undergo the new treatment and will be monitored to see how well they respond. This study aims to provide valuable information that could help improve treatment options for future patients with pulmonary embolism.

Gender

ALL

Eligibility criteria

• 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