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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE | Experimental | Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 48 hours post-procedure |
| 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:
| Within 48 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Thrombolytics Within 48 Hours of the Procedure. | Use of thrombolytics within 48 hours of the procedure. | Within 48 hours of the procedure |
| Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
Excluded from the study if he/she meets any of the following exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| UCLA Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2023 |
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Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
| Within 30 days of the procedure |
| 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. | At 48 hours post-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. | 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 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. | Within 30 days of the procedure |
| Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days. | Symptomatic PE recurrence within 30 days. | Within 30 days of the procedure |
| Los Angeles |
| California |
| 90404 |
| United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| HCA Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Emory University at Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| OSF Healthcare | Peoria | Illinois | 61611 | United States |
| Indiana University | Indianapolis | Indiana | 47405 | United States |
| Community Hospital | Munster | Indiana | 46321 | United States |
| Oshner Medical Center | Jefferson | Louisiana | 70121 | United States |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| Rutgers University | Newark | New Jersey | 07103 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43221 | United States |
| Kettering Health | Miamisburg | Ohio | 45342 | United States |
| UPMC Hamot | Erie | Pennsylvania | 16550 | United States |
| Einstein Medical Center | Montgomery | Pennsylvania | 19403 | United States |
| UPMC Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| Tennova Healthcare -Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| Memorial Hermann (University of Texas at Houston) | Houston | Texas | 77030 | United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Aurora Health Care | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Right Ventricle to Left Ventricle (RV/LV) Ratio | Core lab-adjudicated baseline Right Ventricle to Left Ventricle (RV/LV) ratio | Mean | Standard Deviation | ratio |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | ratio | At 48 hours post-procedure |
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| 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:
| 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. | Posted | Count of Participants | Participants | Within 48 hours post-procedure |
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| Secondary | Use of Thrombolytics Within 48 Hours of the Procedure. | Use of thrombolytics within 48 hours of the procedure. | Modified As Treated population | Posted | Count of Participants | Participants | Within 48 hours of the procedure |
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| 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. | 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. | Posted | Mean | Standard Deviation | days | Within 30 days of the procedure |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | At 48 hours post-procedure |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 48 hours of the procedure |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 30 days of the procedure |
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| Secondary | Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days. | Symptomatic PE recurrence within 30 days. | 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). | Posted | Count of Participants | Participants | Within 30 days of the procedure |
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30 days (+/- 7 days) post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | 0 | 122 | 18 | 122 | 9 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Vascular access site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Staphylococcus test positive | Investigations | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemorrhage | Vascular disorders | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Manning | AngioDynamics, Inc. | 339-237-2765 | liz.manning@angiodynamics.com |
| May 1, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
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