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Tests treatment safety and results for Acute Pulmonary Embolism (PE)
Official title 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
ClinicalTrials.gov ID: NCT06697314
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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:
You likely can't join if
- 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
See the full eligibility 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:
- 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
- Willing and able to provide written informed consent prior to receiving study specific procedures.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Poznan, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poznan, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.