Acute Pulmonary Embolism, Pulmonary Embolism
Conditions
Brief summary
To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
Interventions
DEVICEAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent form. * 18 years of age and older. * Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. * Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). * Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher. * Systolic blood pressure (SBP) of 90 mmHg or higher * Heart rate of 130 beats per minute (BPM) or less prior to the procedure. * Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
Exclusion criteria
Excluded from the study if he/she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA) | At 48 hours post-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. |
| Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure. | Within 48 hours post-procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA). | 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. |
| 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. | 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. |
| Use of Thrombolytics Within 48 Hours of the Procedure. | Within 48 hours of the procedure | Use of thrombolytics within 48 hours of the procedure. |
| Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days. | Within 30 days of the procedure | Symptomatic PE recurrence within 30 days. |
| Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. | Within 30 days of the procedure | Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure. |
| Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure. | Within 30 days of the procedure | Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System |
|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 14.6 |
| Baseline Right Ventricle to Left Ventricle (RV/LV) Ratio | 1.5 ratio STANDARD_DEVIATION 0.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment United States | 122 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 122 |
| other Total, other adverse events | 9 / 122 |
| serious Total, serious adverse events | 18 / 122 |
Outcome results
Primary
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.
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
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 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 |
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure. | Subjects not experiencing a MAE | 117 Participants |
Secondary
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.
Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
Time frame: Within 30 days of the 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| 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 Hospital | 5.2 days | Standard Deviation 3.3 |
Secondary
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.
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.
Time frame: Within 48 hours of the 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 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 |
| 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 without event | 121 Participants |
| 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 pulmonary vascular injury | Subjects with event | 1 Participants |
| 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 pulmonary vascular injury | Subjects without event | 121 Participants |
| 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 cardiac injury | Subjects with event | 1 Participants |
| 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 cardiac injury | Subjects without event | 121 Participants |
| 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. | Major bleeding | Subjects with event | 5 Participants |
| 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. | Major bleeding | Subjects without event | 117 Participants |
| 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 death | Subjects with event | 0 Participants |
| 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 death | Subjects without event | 122 Participants |
Secondary
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.
Time frame: Within 30 days of the 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 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. | Death for any cause | Subjects with event | 0 Participants |
| 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. | Death for any cause | Subjects without event | 122 Participants |
| 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 |
| 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 without event | 118 Participants |
Secondary
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
Symptomatic PE recurrence within 30 days.
Time frame: Within 30 days of the 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 - who completed the study through 30 days (n=118).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days. | 1 Participants |
Secondary
Use of Thrombolytics Within 48 Hours of the Procedure.
Use of thrombolytics within 48 hours of the procedure.
Time frame: Within 48 hours of the procedure
Population: Modified As Treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Use of Thrombolytics Within 48 Hours of the Procedure. | 0 Participants |