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 | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reduction in RV/LV ratio

Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA)

Time frame: 48 hours

Incidence of Adverse Events [Safety and Tolerability]

The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented.

Time frame: 12 months

Secondary Outcomes

Reduction in clot burden

• Reduction in clot burden (measured by refined Modified Miller Index score) between baseline and 48 hours post-procedure assessed by paired CTPA

Time frame: 48 hours

Use of thrombolytics

Use of thrombolytics within 48 hours of the index procedure

Time frame: 48 hours

Change in Biomarkers

Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure

Time frame: 48 hours

Composite Major Adverse Events

* Composite Major Adverse Events within 7 days of the index procedure 1\) PE-related death/deterioration: * Death * Cardiac Arrest * Institution of new vasopressors * ECMO * Mechanical ventilation 2\) Device-related death/deterioration: * Death * BARC 3a/3b/3c/-5 Major Bleeding * Clinical Deterioration * Pulmonary Vascular Injury * Peripheral Vascular Injury * Cardiac Injury * Stroke

Time frame: 7 days

Individual Major Adverse Events

Individual Major Adverse Events within 7 days of the index procedure * PE-related Death * PE-related Cardiac Arrest * PE-related institution of new vasopressors * PE-related ECMO * mechanical ventilation * device-related Death * device-related Major Bleeding * device-related Clinical Deterioration * device-related Pulmonary Vascular Injury * device-related Peripheral Vascular Injury * device-related Cardiac Injury * device-related Stroke

Time frame: 7 days

Days in ITU

Days in ITU post-index procedure admission

Time frame: 7 days

All-cause mortality

All-cause mortality within 30 days of the index procedure

Time frame: 30 days

PE-related mortality

• PE-related mortality within 30 days of the index procedure

Time frame: 30 days

Device-related Serious Adverse Events

Device-related Serious Adverse Events (SAEs) within 30 days of the index procedure

Time frame: 30 days

Days In-patient

Number of days in-patient on index procedure admission

Time frame: 30 days

Hospital readmission

Hospital readmission rate through 30 days

Time frame: 30 days

Symptom burden exercise test

6 minute walking test (MWT) at 30 days post-procedure

Time frame: 30 days

Symptom burden classification

New York Heart Association (NYHA) classification at 30 Days post-procedure

Time frame: 30 Days

Functional outcome review

PROMs at 30 Days post-procedure: * PROMIS Scale v1.2 - Global Health \- PEmb-QoL * Post-VTE Functional Status Scale * PROMIS Short Form v2.0 - Pain Intensity 3a * PROMIS Short Form v1.0 - Dyspnea Severity 10a * PHQ-9 * GAD-7

Time frame: 30 Days

Symptomatic PE recurrence

Symptomatic PE recurrence at 30 days post-procedure

Time frame: 30 days

Symptom burden exercise test

6 minute walking test (MWT) at 6 months post-procedure

Time frame: 6 months

Symptom burden classification

New York Heart Association (NYHA) classification at 6 months post-procedure

Time frame: 6 months

PE-related readmission

\- PE-related hospital readmission rate through 12 months post-procedure

Time frame: 12 months

Symptom burden exercise test

6 minute walking test (MWT) at 12months post-procedure

Time frame: 12 months

Symptom burden classification

New York Heart Association (NYHA) classification at 12 months post-procedure

Time frame: 12 months

Functional outcome review

PROMs at 12 months post-procedure: * PROMIS Scale v1.2 - Global Health \- PEmb-QoL * Post-VTE Functional Status Scale * PROMIS Short Form v2.0 - Pain Intensity 3a * PROMIS Short Form v1.0 - Dyspnea Severity 10a * PHQ-9 * GAD-7

Time frame: 12 months

CTEPH Diagnosis

Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at 12 months post-procedure

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts