Registry for Abbott vascular medical devices

Abbott Vascular Medical Device Registry

Abbott Medical Devices · NCT04573660

This study is collecting information on Abbott vascular medical devices to see how safe and effective they are for patients who have had procedures using these devices.

Quick facts

Study typeObservational
Enrollment3784 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices (industry)
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT04573660 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who are undergoing procedures involving Abbott vascular devices.

Not a fit: Patients with active symptoms or positive test results for COVID-19 or other rapidly spreading infectious agents within the prior two months may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance the safety and effectiveness of Abbott vascular devices, leading to improved patient outcomes.

How similar studies have performed: Other registries focusing on medical devices have shown success in monitoring safety and performance, making this approach a well-established practice.

Eligibility criteria

Show full inclusion / exclusion criteria
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 this trial is running

Birmingham, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism, Arterial Embolism, Coronary and peripheral stents, ABT-CIP-10349, Vascular plugs

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.