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

Not Applicable

Not yet recruiting

• Conditions: Acute Pulmonary Embolism (PE); Pulmonary Embolism

• Registration Number: NCT06697314
• Lead Sponsor: Angiodynamics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-01
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 366

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in RV/LV ratio	48 hours	Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA)
Incidence of Adverse Events [Safety and Tolerability]	12 months	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.

Secondary Outcome Measures

Name	Time	Method
PE-related readmission	12 months	- PE-related hospital readmission rate through 12 months post-procedure
CTEPH Diagnosis	12 months	Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at 12 months post-procedure
Reduction in clot burden	48 hours	• Reduction in clot burden (measured by refined Modified Miller Index score) between baseline and 48 hours post-procedure assessed by paired CTPA
Use of thrombolytics	48 hours	Use of thrombolytics within 48 hours of the index procedure
Change in Biomarkers	48 hours	Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure
Composite Major Adverse Events	7 days	* 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
Individual Major Adverse Events	7 days	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
Days in ITU	7 days	Days in ITU post-index procedure admission
All-cause mortality	30 days	All-cause mortality within 30 days of the index procedure
PE-related mortality	30 days	• PE-related mortality within 30 days of the index procedure
Device-related Serious Adverse Events	30 days	Device-related Serious Adverse Events (SAEs) within 30 days of the index procedure
Days In-patient	30 days	Number of days in-patient on index procedure admission
Hospital readmission	30 days	Hospital readmission rate through 30 days
Symptom burden exercise test	12 months	6 minute walking test (MWT) at 12months post-procedure
Symptom burden classification	12 months	New York Heart Association (NYHA) classification at 12 months post-procedure
Functional outcome review	12 months	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
Symptomatic PE recurrence	30 days	Symptomatic PE recurrence at 30 days post-procedure