Actively Recruiting
Abbott Vascular Medical Device Registry
Led by Abbott Medical Devices · Updated on 2025-07-03
3784
Participants Needed
37
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools FFR and OCT, peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closurecompression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.
CONDITIONS
Brief Title
Abbott Vascular Medical Device Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
Research Team
S
Sharan Dhanjal, MPH
C
Chinedu Agbonghai, MS
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