Registry tracking safety of Abbott heart and vessel devices in patients
Collects data on Abbott stents and catheters used in adults with heart or vessel disease.
Plain-language title generated from the registry record
Registry title: Abbott Vascular Medical Device Registry
Key facts
- Where
- Birmingham, Chicago, Columbus, Kingsport, Lincoln, Little Rock, and Los Angeles, United StatesSee the 7 sites
Where in United States
- University Hospital - Univ. of Alabama at Birmingham (UAB)Birmingham, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- Ohio State UniversityColumbus, United StatesTaking people
- Wellmont CVA Heart InstituteKingsport, United StatesTaking people
- Bryan HeartLincoln, United StatesTaking people
- Arkansas Heart HospitalLittle Rock, United StatesTaking people
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abbott Medical Devices
- Trial code
- NCT04573660
- Record updated
- 13 October 2026
- Original 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.Read full original descriptionShow less
Abbott Vascular Medical Device Registry
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.
Inclusion: 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.
Exclusion: 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.