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.
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.
None
This study will enroll subjects 18 years and older of all genders in which at least one Abbott target device specified in the CIP is used. Outcomes will be collected on any ancillary devices in scope, but patients will not be enrolled for use of an ancillary device without treatment with any target device. Patients must meet all general eligibility criteria and provide written informed consent or be enrolled under an IRB/EC approved waiver of consent, prior to sites' collection of patient data for the investigation.
Cohort
Prospective
Coronary and peripheral stents
DeviceThe participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Pacing catheters
DeviceThe participants in the Pacing catheters arm will receive Pacing catheters
Vascular plugs
DeviceThe participants in the Vascular plugs arm will receive Vascular plugs
Measurement and imaging (FFR and OCT)
DeviceThe participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
Peripheral dilatation catheters
DeviceThe participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
Coronary dilatation catheters
DeviceThe participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Coronary and peripheral guidewires
DeviceThe participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
Vessel closure/compression devices
DeviceThe participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
Vascular access introducers
DeviceThe participants in the Vascular access introducers arm will receive Vascular access introducers
9
Treatment groupsSee each treatment group below.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Click on the lead sponsor to view all of their trials.
