Abbott Vascular Medical Device Registry

Recruiting now

Conditions studied: Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism, Arterial Embolism

In brief

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.

Key facts

Study ID

NCT04573660

Run by

Abbott Medical Devices

People needed

3784

Starts

2020-10-25

Expected to finish

2031-11-01

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is at least 18 years of age.
• Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
• Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
• 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.

You may not qualify if…

• 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.

Where it is running

• Al Qassimi Hospital — Sharjah city, Emirate of Sharjah, United Arab Emirates (enrolling)
• Arkansas Heart Hospital — Little Rock, Arkansas, United States (enrolling)
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Bryan Heart — Lincoln, Nebraska, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States (enrolling)
• Perth Institute of Vascular Research — Nedlands, WAUS, Australia (enrolling)
• Sir Charles Gairdner Hospital — Nedlands, WAUS, Australia (enrolling)
• Universitätsklinik Graz — Graz, Styria, Austria (enrolling)
• Onze-Lieve-Vrouwziekenhuis Campus Aalst — Aalst, Eflndrs, Belgium (enrolling)
• AZ Sint-Blasius Ziekenhuis — Dendermonde, Eflndrs, Belgium (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)
• Jinhua Municipal Central Hospital — Jinhua, Zhejian, China (enrolling)
• Ningbo First Hospital — Ningbo, Zhejian, China (enrolling)
• CH Chartres — Chartres, Centre-Val de Loire, France (enrolling)
• National Cheng Kung University Hospital — Tainan, Staiwan, Taiwan (enrolling)
• Chi Mei Hospital — Tainan, Staiwan, Taiwan (enrolling)
• University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States (enrolling)
• Cardioangiologisches Centrum am Bethanien Krankenhaus — Frankfurt am Main, Hesse, Germany (enrolling)
• UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz — Mainz, Rhinela, Germany (enrolling)
• Universitätsklinikum Leipzig AÖR — Leipzig, Saxony, Germany (enrolling)
• Herz- u. Gefäßzentrum Bad Bevensen — Bad Bevensen, Saxon, Germany (enrolling)
• Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel, Schlesw, Germany (enrolling)
• Semmelweis University — Budapest, Budapest, Hungary (enrolling)

Full record on ClinicalTrials.gov

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