Registry for Abbott vascular medical devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Abbott Vascular Medical Device Registry is a prospective, non-randomized, open-label, multi-center registry designed to collect and evaluate clinical data on the use of specific Abbott medical devices. This registry aims to confirm the safety and performance of these devices throughout their expected lifetime, monitor emerging risks, and ensure the benefit-risk ratio remains acceptable. By proactively gathering data, the registry seeks to identify any systematic misuse or off-label usage of the devices. Participants will be monitored based on their planned or completed procedures involving these devices.

Why it matters

Who can join: the full rules

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 rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.

Where it's running

• University Hospital - Univ. of Alabama at Birmingham (UAB)
  Birmingham, Alabama, United States Recruiting
• Arkansas Heart Hospital
  Little Rock, Arkansas, United States Recruiting
• Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• Bryan Heart
  Lincoln, Nebraska, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Sharan Dhanjal, MPH
• Email: sharanjeet.dhanjal@abbott.com
• Phone: +1 714-926-8292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.