Abbott Vascular Medical Device Registry
Abbott Medical Devices
3,784 participants
Oct 25, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria1
- \. 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
The participants in the Pacing catheters arm will receive Pacing catheters
The participants in the Vascular plugs arm will receive Vascular plugs
The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
The participants in the Vascular access introducers arm will receive Vascular access introducers
Locations(37)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04573660