Trial Outcomes & Findings for Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism (NCT NCT05318092)

Last Updated: 2024-07-19

Results Overview

Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab.

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

At 48 hours post-procedure

Results posted on

2024-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Overall Study STARTED	122
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=122 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Age, Continuous	61.9 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	34 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants
Baseline Right Ventricle to Left Ventricle (RV/LV) Ratio	1.5 ratio STANDARD_DEVIATION 0.31 • n=5 Participants

PRIMARY outcome

Timeframe: At 48 hours post-procedure

Population: Modified As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins, who did not receive thrombolytics during the index procedure.

Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=119 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)	-0.45 ratio Standard Deviation 0.27

PRIMARY outcome

Timeframe: Within 48 hours post-procedure

Population: As Treated population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins.

Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding Device-related SAEs of: * Clinical Deterioration * Pulmonary Vascular Injury * Cardiac Injury

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=122 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure. Subjects experiencing a MAE	5 Participants
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure. Subjects not experiencing a MAE	117 Participants

SECONDARY outcome

Timeframe: Within 48 hours of the procedure

Population: Modified As Treated population

Use of thrombolytics within 48 hours of the procedure.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=119 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Use of Thrombolytics Within 48 Hours of the Procedure.	0 Participants

SECONDARY outcome

Timeframe: Within 30 days of the procedure

Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=119 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure. Length of Stay in ICU	1.4 days Standard Deviation 1.7
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure. Length of Stay in Hospital	5.2 days Standard Deviation 3.3

SECONDARY outcome

Timeframe: At 48 hours post-procedure

Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=119 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).	-5.6 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Within 48 hours of the procedure

Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=122 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related clinical deterioration · Subjects with event	1 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related clinical deterioration · Subjects without event	121 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related pulmonary vascular injury · Subjects with event	1 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related pulmonary vascular injury · Subjects without event	121 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related cardiac injury · Subjects with event	1 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related cardiac injury · Subjects without event	121 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Major bleeding · Subjects with event	5 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Major bleeding · Subjects without event	117 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related death · Subjects with event	0 Participants
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Device-related death · Subjects without event	122 Participants

SECONDARY outcome

Timeframe: Within 30 days of the procedure

Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=122 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. Device-related SAEs · Subjects with event	4 Participants
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. Device-related SAEs · Subjects without event	118 Participants
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. Death for any cause · Subjects with event	0 Participants
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. Death for any cause · Subjects without event	122 Participants

SECONDARY outcome

Timeframe: Within 30 days of the procedure

Symptomatic PE recurrence within 30 days.

Outcome measures

Outcome measures
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=118 Participants AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.	1 Participants

Adverse Events

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Serious events: 18 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=122 participants at risk AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Cardiac disorders Acute myocardial infarction	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Cardiac disorders Arrhythmia	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Cardiac disorders Cardiogenic shock	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Cardiac disorders Supraventricular tachycardia	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
General disorders Non-cardiac chest pain	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Hepatobiliary disorders Cholelithiasis	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Injury, poisoning and procedural complications Vascular access site pain	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Investigations Staphylococcus test positive	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Metabolism and nutrition disorders Gout	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Nervous system disorders Seizure	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Renal and urinary disorders Acute kidney injury	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 2/122 • Number of events 2 • 30 days (+/- 7 days) post-procedure
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Vascular disorders Haemorrhage	4.1% 5/122 • Number of events 5 • 30 days (+/- 7 days) post-procedure
Vascular disorders Hypertensive emergency	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Vascular disorders Hypotension	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Vascular disorders Hypovolaemic shock	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure
Vascular disorders Orthostatic hypotension	0.82% 1/122 • Number of events 1 • 30 days (+/- 7 days) post-procedure

Other adverse events

Other adverse events
Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n=122 participants at risk AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Vascular disorders Deep vein thrombosis	7.4% 9/122 • Number of events 9 • 30 days (+/- 7 days) post-procedure

Additional Information

Elizabeth Manning

AngioDynamics, Inc.

Phone: 339-237-2765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The publication of the results from any single site experience within the study is not allowed until the preparation and publication of the multi-center results. Exceptions to this rule require the prior written approval of the Sponsor. If after 180 days from the conclusion of the study, the Sponsor has not published the results, the investigators may publish without prior approval from the Sponsor.
Publication restrictions are in place

Restriction type: OTHER