Abbott Vascular Medical Device Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Coronary and peripheral stents
  • Pacing catheters
  • Vascular plugs
  • Measurement and imaging (FFR and OCT)
  • Peripheral dilatation catheters
  • Coronary dilatation catheters
  • Coronary and peripheral guidewires
  • Vessel closure/compression devices
  • Vascular access introducers

Treatment groups

3,784 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators