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 type | Observational |
|---|---|
| Enrollment | 3784 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices (industry) |
| Locations | 37 sites (Birmingham, Alabama and 36 other locations) |
| Trial ID | NCT04573660 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
- 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)
- Wellmont CVA Heart Institute — Kingsport, Tennessee, United States (RECRUITING)
- Perth Institute of Vascular Research — Nedlands, WAUS, Australia (RECRUITING)
- Sir Charles Gairdner Hospital — Nedlands, WAUS, Australia (RECRUITING)
- Universitätsklinik Graz — Graz, Styria, Austria (RECRUITING)
- Onze-Lieve-Vrouwziekenhuis Campus Aalst — Aalst, Eflndrs, Belgium (RECRUITING)
- AZ Sint-Blasius Ziekenhuis — Dendermonde, Eflndrs, Belgium (RECRUITING)
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)
- Jinhua Municipal Central Hospital — Jinhua, Zhejian, China (RECRUITING)
- Ningbo First Hospital — Ningbo, Zhejian, China (RECRUITING)
- CH Chartres — Chartres, Centre-Val de Loire, France (RECRUITING)
- Hôpital Paris Saint-Joseph — Paris, Ile, France (COMPLETED)
- Cardioangiologisches Centrum am Bethanien Krankenhaus — Frankfurt am Main, Hesse, Germany (RECRUITING)
- UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz — Mainz, Rhinela, Germany (RECRUITING)
- Universitätsklinikum Leipzig AÖR — Leipzig, Saxony, Germany (RECRUITING)
- Herz- u. Gefäßzentrum Bad Bevensen — Bad Bevensen, Saxon, Germany (RECRUITING)
- Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel, Schlesw, Germany (RECRUITING)
- Semmelweis University — Budapest, Budapest, Hungary (RECRUITING)
- Ospedale San Raffaele — Milan, Lombard, Italy (COMPLETED)
- Centro Cardiologico Monzino — Milan, Lombard, Italy (RECRUITING)
- Policlinico San Donato — San Donato Milanese, Lombard, Italy (RECRUITING)
- St. Antonius Ziekenhuis — Nieuwegein, Utrecht, Netherlands (COMPLETED)
- Hospital Universitari Vall d'Hebron — Barcelona, Catalon, Spain (RECRUITING)
- Hospital Universitario de la Paz — Madrid, Madrid, Spain (RECRUITING)
- Hospital General Universitario de Alicante — Alicante, Valncia, Spain (RECRUITING)
- Kantonsspital Aarau — Aarau, Basel, Switzerland (RECRUITING)
- Inselspital - University Hospital of Bern — Bern, Canton of Bern, Switzerland (RECRUITING)
- Taichung Veterans General Hospital — Taichung, Mtaiwan, Taiwan (RECRUITING)
- Cathay General Hospital — Taipei, Ntaiwan, Taiwan (RECRUITING)
- National Cheng Kung University Hospital — Tainan, Staiwan, Taiwan (RECRUITING)
- Chi Mei Hospital — Tainan, Staiwan, Taiwan (RECRUITING)
- Al Qassimi Hospital — Sharjah city, Emirate of Sharjah, United Arab Emirates (RECRUITING)
Study contacts
- Study coordinator: Sharan Dhanjal, MPH
- Email: sharanjeet.dhanjal@abbott.com
- Phone: +1 714-926-8292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism, Arterial Embolism, Coronary and peripheral stents, ABT-CIP-10349, Vascular plugs