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

NCT05318092 | Completed Results DMC FDA Device

• 1 other identifier: 2021-EVT-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 25

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).

Conditions

Pulmonary Embolism; Acute Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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: * Clinical Deterioration * Pulmonary Vascular Injury * Cardiac Injury

  Within 48 hours post-procedure

Secondary Outcomes (6)

• 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.

  Within 30 days of the procedure

• Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).

  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.

  Within 48 hours of the 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

Study Arms (1)

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

Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Interventions

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.

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (25)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

UCLA Health

Los Angeles, California, 90404, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

HCA Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Emory University at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

OSF Healthcare

Peoria, Illinois, 61611, United States

Location

Indiana University

Indianapolis, Indiana, 47405, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Oshner Medical Center

Jefferson, Louisiana, 70121, United States

Location

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

Kettering Health

Miamisburg, Ohio, 45342, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

Einstein Medical Center

Montgomery, Pennsylvania, 19403, United States

Location

UPMC Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Tennova Healthcare -Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Memorial Hermann (University of Texas at Houston)

Houston, Texas, 77030, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Elizabeth Manning
• Organization: AngioDynamics, Inc.

liz.manning@angiodynamics.com

339-237-2765

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 8, 2022
• Study Start: October 19, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-07

Locations

US (25)