Removing lung blood clots with the AlphaVac mechanical aspiration device
Prospective, Multicenter, Multi-national, Single Arm Trial 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
This trial tests whether using the AlphaVac mechanical aspiration device to remove clots helps adults with recent acute pulmonary embolism and signs of right-heart strain or clinical compromise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Angiodynamics, Inc. Industry-sponsored |
| Locations | 1 site (Poznan) |
| Trial ID | NCT06697314 on ClinicalTrials.gov |
What this trial studies
This interventional study uses percutaneous mechanical aspiration thrombectomy with the AlphaVac MMA F1885 System to remove pulmonary artery clots in adults with CTPA-proven acute pulmonary embolism of ≤14 days. Eligible participants have evidence of right ventricular strain (RV/LV ≥1.0) and elevated troponin, plus clinical signs such as tachycardia, low-normal blood pressure, low oxygen levels, or known heart failure. The study will track procedure safety, immediate efficacy in clot removal and right-heart metrics, and longer-term functional outcomes. Patients with contraindications to therapeutic anticoagulation or significant comorbidities limiting life expectancy are excluded.
Who should consider this trial
Good fit: Adults (≥18 years) with symptomatic, CTPA-confirmed acute PE within 14 days, RV/LV ratio ≥1.0, elevated troponin, and at least one sign of hemodynamic or respiratory compromise who can receive anticoagulation are the ideal candidates.
Not a fit: Patients who cannot receive therapeutic anticoagulation, have chronic or very distal small clots, or have severe comorbidities with limited life expectancy may not benefit from this procedure.
Why it matters
Potential benefit: If successful, the procedure could more quickly remove clots, improve right-ventricular function, relieve symptoms, and reduce longer-term disability from pulmonary embolism.
How similar studies have performed: Prior registry and single-arm device studies of mechanical thrombectomy for acute PE have shown promising improvements in clot burden and right-heart metrics, but randomized long-term outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Poznan
- Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
Study contacts
- Principal investigator: Andrew Sharp — University College Dublin, Rep. of Ireland
- Study coordinator: Mitch Vanderpoll
- Email: mvanderpoll@angiodynamics.com
- Phone: +447790921819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.