Clinical trial NCT06697314: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pulmonary Embolism (PE)
Pulmonary Embolism
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in RV/LV ratio
timeFrame: 48 hours
measure: Incidence of Adverse Events [Safety and Tolerability]
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in clot burden
timeFrame: 48 hours
measure: Use of thrombolytics
timeFrame: 48 hours
measure: Change in Biomarkers
timeFrame: 48 hours
measure: Composite Major Adverse Events
timeFrame: 7 days
measure: Individual Major Adverse Events
timeFrame: 7 days
measure: Days in ITU
timeFrame: 7 days
measure: All-cause mortality
timeFrame: 30 days
measure: PE-related mortality
timeFrame: 30 days
measure: Device-related Serious Adverse Events
timeFrame: 30 days
measure: Days In-patient
timeFrame: 30 days
measure: Hospital readmission
timeFrame: 30 days
measure: Symptom burden exercise test
timeFrame: 30 days
measure: Symptom burden classification
timeFrame: 30 Days
measure: Functional outcome review
timeFrame: 30 Days
measure: Symptomatic PE recurrence
timeFrame: 30 days
measure: Symptom burden exercise test
timeFrame: 6 months
measure: Symptom burden classification
timeFrame: 6 months
measure: Functional outcome review
timeFrame: 6 months
measure: PE-related readmission
timeFrame: 12 months
measure: Symptom burden exercise test
timeFrame: 12 months
measure: Symptom burden classification
timeFrame: 12 months
measure: Functional outcome review
timeFrame: 12 months
measure: CTEPH Diagnosis
timeFrame: 12 months
Other outcomes:
measure: Cardiac MRI
timeFrame: 12 months
measure: Peak Oxygen Consumption
timeFrame: 12 months
Locations:
Study officials:
References: