Clinical trial NCT05318092: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Official title: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Acute Pulmonary Embolism
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 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.
* Fraction of inspired oxygen (FiO2) requirement \>40% or \>6 liters per minute (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 ≥ 90 mmHg.
* 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

Primary outcomes:
measure: Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)
timeFrame: At 48 hours post-procedure
measure: Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.
timeFrame: Within 48 hours post-procedure
Secondary outcomes:
measure: Use of Thrombolytics Within 48 Hours of the Procedure.
timeFrame: Within 48 hours of the procedure
measure: Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.
timeFrame: Within 30 days of the procedure
measure: Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).
timeFrame: At 48 hours post-procedure
measure: 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.
timeFrame: Within 48 hours of the procedure
measure: Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.
timeFrame: Within 30 days of the procedure
measure: Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
timeFrame: Within 30 days of the procedure
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: HCA Memorial Hospital Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University at Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Peoria
country: United States
facility: OSF Healthcare
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Jefferson
country: United States
facility: Oshner Medical Center
state: Louisiana
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Center
state: Minnesota
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Miamisburg
country: United States
facility: Kettering Health
state: Ohio
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Montgomery
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Pittsburgh
state: Pennsylvania
city: Knoxville
country: United States
facility: Tennova Healthcare -Turkey Creek Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann (University of Texas at Houston)
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
References: