Abbott Vascular Medical Device Registry

  • STATUS
    Recruiting
  • End date
    Nov 20, 2031
  • participants needed
    3784
  • sponsor
    Abbott Medical Devices
Updated on 20 April 2021

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.

Details
Condition Coronary Restenosis, Acute Myocardial Infarction, Critical Limb Ischemia, Critical Limb Ischaemia, Coronary Artery Lesions, Symptomatic Ischemic Heart Disease, arterial embolism, Venous Embolism
Treatment XIENCE PRIME BTK stent, Absolute Pro LL stent, Supera 7.5 OD stent, Xpert Pro stent, Pacel BPC, Pacel FDPC, AVP I, AVP II, AVP 4, PressureWire X, MULTI-LINK 8 stent, MULTI-LINK 8 LL stent, MULTI-LINK 8 SV stent
Clinical Study IdentifierNCT04573660
SponsorAbbott Medical Devices
Last Modified on20 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 or competitive 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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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