Abbott Vascular Medical Device Registry

Description

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Conditions

Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism, Arterial Embolism

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Study Overview

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Study Details

Study overview

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Abbott Vascular Medical Device Registry

Abbott Vascular Medical Device Registry

Condition
Acute Myocardial Infarction
Intervention / Treatment

-

Contacts and Locations

Birmingham

University Hospital - Univ. of Alabama at Birmingham (UAB), Birmingham, Alabama, United States, 35249

Little Rock

Arkansas Heart Hospital, Little Rock, Arkansas, United States, 72211

Los Angeles

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States, 90027

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Lincoln

Bryan Heart, Lincoln, Nebraska, United States, 68506

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Kingsport

Wellmont CVA Heart Institute, Kingsport, Tennessee, United States, 37660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject is at least 18 years of age.
  • 2. Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
  • 3. Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
  • 4. Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent.
  • 1. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Chananit Hutson, PhD, STUDY_DIRECTOR, Abbott Medical Devices

Study Record Dates

2031-11