Abbott Vascular Medical Device Registry
Purpose
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.
Conditions
- Acute Myocardial Infarction
- Restenoses, Coronary
- Coronary Artery Lesions
- Venous Embolism
- Arterial Embolism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Coronary and peripheral stents | Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents |
|
| Pacing catheters | Participants in the Pacing catheters arm will receive Pacing catheters |
|
| Vascular plugs | Participants in the Vascular plugs arm will receive Vascular plugs |
|
| Measurement and imaging (FFR and OCT) | Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT) |
|
| Peripheral dilatation catheters | Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters |
|
| Coronary dilatation catheters | Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters |
|
| Coronary and peripheral guidewires | Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires |
|
| Vessel closure/compression devices | Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices |
|
| Vascular access introducers | Participants in the Vascular access introducers devices arm will receive Vascular access introducers |
|
Recruiting Locations
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama 35249
Birmingham, Alabama 35249
More Details
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices