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

Pulmonary Embolism Clinical Trial

— APEX-AV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318092
• Other study ID #: 2021-EVT-01
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

• RV/LV ratio of 0.9 or higher.

• Systolic blood pressure (SBP) of 90mmHg 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 exclusion criteria

• May be pregnant as determined by a positive pregnancy test or who are breastfeeding.

• Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.

• Has used thrombolytics (tPA) in the past 30 days of baseline CTA.

• Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.

• FiO2 requirement >40% or >6 LPM to keep oxygen saturations >90%

• Hematocrit <28% within 6 hours of the index procedure.

• Platelets count < 100,000/µL.

• Serum creatinine >1.8 mg/dL.

• International Normalized Ratio (INR) > 3

• Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15.

• Presence of cancer requiring active chemotherapy.

• Known bleeding diathesis or coagulation disorder.

• Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.

• History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction = 30%.

• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.

• Requires Vasopressor after fluids to keep pressure = 90mmHg.

• With left bundle branch block.

• Has intracardiac lead in the right ventricle or atrium.

• Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.

• Has life expectancy < 90 days.

• Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).

• Participation in another investigational study

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Intervention

Device:
• AlphaVac 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.

Locations

Country	Name	City	State
United States	Emory University at Grady Memorial Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Jacobi Medical Center	Bronx	New York
United States	University of Buffalo	Buffalo	New York
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	UPMC Hamot	Erie	Pennsylvania
United States	Memorial Hermann (University of Texas at Houston)	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	HCA Memorial Hospital Jacksonville	Jacksonville	Florida
United States	Oshner Medical Center	Jefferson	Louisiana
United States	Tennova Healthcare -Turkey Creek Medical Center	Knoxville	Tennessee
United States	UCLA Health	Los Angeles	California
United States	Kettering Health	Miamisburg	Ohio
United States	Aurora Health Care	Milwaukee	Wisconsin
United States	Einstein Medical Center	Montgomery	Pennsylvania
United States	Community Hospital	Munster	Indiana
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Rutgers University	Newark	New Jersey
United States	OSF Healthcare	Peoria	Illinois
United States	UPMC Pittsburgh	Pittsburgh	Pennsylvania
United States	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota
United States	Methodist Hospital	San Antonio	Texas
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.	Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.	At 48 hours post-procedure
Primary	Rate of Major Adverse Events (MAEs) within the first 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 which includes: Clinical Deterioration; Pulmonary Vascular Injury; Cardiac Injury	At 48 hours post-procedure
Secondary	Use of thrombolytics within 48 hours of the procedure.	Use of thrombolytics within 48 hours of the procedure.	Within 48 hours of the procedure
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.	Within 30 days of the procedure
Secondary	Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.	Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.	At 48 hours post-procedure
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.	Within 48 hours of the procedure
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.	Within 30 days of the procedure
Secondary	Symptomatic PE recurrence within 30 days.	Symptomatic PE recurrence within 30 days.	Within 30 days of the procedure