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

Primary Purpose

Pulmonary Embolism, Acute Pulmonary Embolism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Sponsored by
Angiodynamics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HonorHealthRecruiting
  • UCLA HealthRecruiting
  • Yale UniversityRecruiting
  • Delray Medical Center/ Prima Vascular Institute/ Tenet Florida Physician ServicesRecruiting
  • HCA Memorial Hospital JacksonvilleRecruiting
  • Emory University at Grady Memorial HospitalRecruiting
  • Piedmont Heart InstituteRecruiting
  • OSF HealthcareRecruiting
  • Indiana UniversityRecruiting
  • Community HospitalRecruiting
  • Oshner Medical CenterRecruiting
  • CentraCare Heart and Vascular CenterRecruiting
  • Washington University School of MedicineRecruiting
  • Virtua HealthRecruiting
  • Rutgers UniversityRecruiting
  • Jacobi Medical CenterRecruiting
  • University of BuffaloRecruiting
  • Mount Sinai Ichan School of MedicineRecruiting
  • Columbia University Medical Center/NYPHRecruiting
  • Ohio State University Wexner Medical CenterRecruiting
  • Kettering HealthRecruiting
  • UPMC HamotRecruiting
  • Einstein Medical CenterRecruiting
  • Tennova Healthcare -Turkey Creek Medical CenterRecruiting
  • Baylor Heart and Vascular HospitalRecruiting
  • Memorial Hermann (University of Texas at Houston)Recruiting
  • Methodist HospitalRecruiting
  • Aurora Health CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Arm Description

Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Use of thrombolytics within 48 hours of the procedure.
Use of thrombolytics within 48 hours of the procedure.
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.
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.
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.
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.
Symptomatic PE recurrence within 30 days.
Symptomatic PE recurrence within 30 days.

Full Information

First Posted
March 24, 2022
Last Updated
September 20, 2023
Sponsor
Angiodynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05318092
Brief Title
Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Acronym
APEX-AV
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiodynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Acute Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Arm Type
Experimental
Arm Description
Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism
Intervention Type
Device
Intervention Name(s)
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Description
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Time Frame
At 48 hours post-procedure
Title
Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure.
Description
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
Time Frame
At 48 hours post-procedure
Secondary Outcome Measure Information:
Title
Use of thrombolytics within 48 hours of the procedure.
Description
Use of thrombolytics within 48 hours of the procedure.
Time Frame
Within 48 hours of the procedure
Title
Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
Description
Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
Time Frame
Within 30 days of the procedure
Title
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.
Description
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.
Time Frame
At 48 hours post-procedure
Title
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.
Description
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
Title
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.
Description
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
Title
Symptomatic PE recurrence within 30 days.
Description
Symptomatic PE recurrence within 30 days.
Time Frame
Within 30 days of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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). 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Manning
Phone
339-237-2765
Email
liz.manning@angiodynamics.com
Facility Information:
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Gaughan
Phone
480-323-1046
Email
agaughan@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Taral Patel, MD
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Rueda
Phone
310-562-9694
Email
vrueda@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Mona Ranade, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Fugal
Phone
203-785-4855
Email
patricia.fugal@yale.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Pollak, MD
Facility Name
Delray Medical Center/ Prima Vascular Institute/ Tenet Florida Physician Services
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Minnerly
Phone
561-303-0013
Email
christopher.minnerly@tenethealth.com
First Name & Middle Initial & Last Name & Degree
Joseph Ricotta, MD
Facility Name
HCA Memorial Hospital Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Breting
Email
elizabeth.breting@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Mohannad Bisharat, MD
Facility Name
Emory University at Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherin Bachman
Phone
404-251-8916
Email
katherine.bachman@emory.edu
First Name & Middle Initial & Last Name & Degree
Christopher Ramos, MD
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Corley
Email
suzanne.corley@piedmont.org
First Name & Middle Initial & Last Name & Degree
Andrew Klein, MD
Facility Name
OSF Healthcare
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Hartwig
Phone
309-655-4229
Email
kimberly.hartwig@osfhealthcare.org
First Name & Middle Initial & Last Name & Degree
Daniel Gans, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Grubbs
Email
eegrubbs@iu.edu
First Name & Middle Initial & Last Name & Degree
Sabah Butty, MD
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tera Gagne
Phone
219-703-1152
Email
tera.m.gagne@comhs.org
First Name & Middle Initial & Last Name & Degree
Dean Ferrera, DO
Facility Name
Oshner Medical Center
City
Jefferson
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Harrison
Email
michael.harrison@ochsner.org
First Name & Middle Initial & Last Name & Degree
James Jenkins, MD
Facility Name
CentraCare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Stock
Phone
320-251-2700
Ext
58315
Email
stockl@centracare.com
First Name & Middle Initial & Last Name & Degree
Brian Stegman, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Cosentino
Phone
314-362-6257
Email
ashley.cosentino@wustl.edu
First Name & Middle Initial & Last Name & Degree
Vipul Khetarpaul, MD
Facility Name
Virtua Health
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Broderick
Phone
856-355-1225
Email
KBroderick@virtua.org
First Name & Middle Initial & Last Name & Degree
Ibrahim Moussa, DO
Facility Name
Rutgers University
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanille Taveras
Email
taveraya@njms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Pratik Shukla, MD
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cidney Schultz
Email
cidney.schultz@nychhc.org
First Name & Middle Initial & Last Name & Degree
Seth Sokol, MD
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Bishop
Phone
716-888-4839
Email
cabishop@buffalo.edu
First Name & Middle Initial & Last Name & Degree
David Zlotnick, MD
Facility Name
Mount Sinai Ichan School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Greenberg
Phone
212-636-8705
Email
aaron.greenberg@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Robert Lookstein, MD
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kartik Kodali
Email
kk3544@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Sanjum Sethi, MD
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Prather
Email
Evan.Prather@osumc.edu
First Name & Middle Initial & Last Name & Degree
Raymond Magorien, MD
Facility Name
Kettering Health
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Seger
Email
chris.seger@ketteringhealth.org
First Name & Middle Initial & Last Name & Degree
Ammar Safar, MD
Facility Name
UPMC Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawna Chylinski
Email
chylinskisj@upmc.edu
First Name & Middle Initial & Last Name & Degree
Robert Maholic, DO
Facility Name
Einstein Medical Center
City
Montgomery
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meera Kasireddy
Phone
215-456-6370
Email
meera.kasireddy@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Kenneth Cho, MD
First Name & Middle Initial & Last Name & Degree
Paul Brady, MD
Facility Name
Tennova Healthcare -Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Polk
Phone
865-392-3400
Email
beth.polk@tennova.com
First Name & Middle Initial & Last Name & Degree
Malcolm Foster, MD
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Baker
Phone
214-820-9903
Email
rebecca.baker2@bswhealth.org
First Name & Middle Initial & Last Name & Degree
Zachary Rosol, MD
Facility Name
Memorial Hermann (University of Texas at Houston)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brody Judice
Phone
713-704-4300
Email
brody.judice@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sukhdeep Basra, MD
First Name & Middle Initial & Last Name & Degree
Danny Ramzy, MD
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurene Cantu
Phone
210-575-7863
Email
maurene.cantu@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Chandra Kunavarapu, MD
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Anderson
Email
sara.klein@aah.org
First Name & Middle Initial & Last Name & Degree
Khawaja Ammar, MD

12. IPD Sharing Statement

Learn more about this trial

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

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