Abbott Vascular Medical Device Registry
Abbott Medical Devices
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 r…
Interventions
- DeviceCoronary and peripheral stents
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
- DevicePacing catheters
The participants in the Pacing catheters arm will receive Pacing catheters
- DeviceVascular plugs
The participants in the Vascular plugs arm will receive Vascular plugs
- DeviceMeasurement and imaging (FFR and OCT)
The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
- DevicePeripheral dilatation catheters
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
- DeviceCoronary dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Locations (37)
- University Hospital - Univ. of Alabama at Birmingham (UAB)Birmingham, Alabama
- Arkansas Heart HospitalLittle Rock, Arkansas
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
- Northwestern Memorial HospitalChicago, Illinois
- Bryan HeartLincoln, Nebraska
- Ohio State UniversityColumbus, Ohio