RecruitingNot Applicable

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

Poland256 participantsStarted 2025-06-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis
✓. Systolic blood pressure ≤ 110mmHg for at least 15 minutes
✓. 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
✓. Known history of heart failure

What they're measuring

Reduction in RV/LV ratio

Timeframe: 48 hours

Incidence of Adverse Events [Safety and Tolerability]

Timeframe: 12 months

Trial details

NCT IDNCT06697314

SponsorAngiodynamics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Mitch Vanderpoll

+447790921819 mvanderpoll@angiodynamics.com

View on ClinicalTrials.gov More Acute Pulmonary Embolism (PE) trials