Home › Ornithine Carbamoyltransferase Deficiency Disease › NCT04573660
Abbott Vascular Medical Device Registry
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion 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. Exclusion Criteria: 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.
About the study
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.
What is being tested
- Coronary and peripheral stents (device)
- Pacing catheters (device)
- Vascular plugs (device)
- Measurement and imaging (FFR and OCT) (device)
- Peripheral dilatation catheters (device)
- Coronary dilatation catheters (device)
Sponsor: Abbott Medical Devices · Participants: 3,784 · Started: Oct 25, 2020
Contact the study team
- Sharan Dhanjal, MPH · Phone: +1 714-926-8292
Official record on ClinicalTrials.gov — NCT04573660
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.