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Abbott Vascular Medical Device Registry
Sponsor: Abbott Medical Devices
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3784
Start Date
2020-10-25
Completion Date
2031-11
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
Coronary and peripheral stents
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Pacing catheters
The participants in the Pacing catheters arm will receive Pacing catheters
Vascular plugs
The participants in the Vascular plugs arm will receive Vascular plugs
Measurement and imaging (FFR and OCT)
The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
Peripheral dilatation catheters
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
Coronary dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Coronary and peripheral guidewires
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
Vessel closure/compression devices
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
Vascular access introducers
The participants in the Vascular access introducers arm will receive Vascular access introducers
Locations (37)
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Bryan Heart
Lincoln, Nebraska, United States
Ohio State University
Columbus, Ohio, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Perth Institute of Vascular Research
Nedlands, WAUS, Australia
Sir Charles Gairdner Hospital
Nedlands, WAUS, Australia
Universitätsklinik Graz
Graz, Styria, Austria
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst, Eflndrs, Belgium
AZ Sint-Blasius Ziekenhuis
Dendermonde, Eflndrs, Belgium
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Jinhua Municipal Central Hospital
Jinhua, Zhejian, China
Ningbo First Hospital
Ningbo, Zhejian, China
CH Chartres
Chartres, Centre-Val de Loire, France
Hôpital Paris Saint-Joseph
Paris, Ile, France
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela, Germany
Universitätsklinikum Leipzig AÖR
Leipzig, Saxony, Germany
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, Saxon, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schlesw, Germany
Semmelweis University
Budapest, Budapest, Hungary
Ospedale San Raffaele
Milan, Lombard, Italy
Centro Cardiologico Monzino
Milan, Lombard, Italy
Policlinico San Donato
San Donato Milanese, Lombard, Italy
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Catalon, Spain
Hospital Universitario de la Paz
Madrid, Madrid, Spain
Hospital General Universitario de Alicante
Alicante, Valncia, Spain
Kantonsspital Aarau
Aarau, Basel, Switzerland
Inselspital - University Hospital of Bern
Bern, Canton of Bern, Switzerland
Taichung Veterans General Hospital
Taichung, Mtaiwan, Taiwan
Cathay General Hospital
Taipei, Ntaiwan, Taiwan
National Cheng Kung University Hospital
Tainan, Staiwan, Taiwan
Chi Mei Hospital
Tainan, Staiwan, Taiwan
Al Qassimi Hospital
Sharjah city, Emirate of Sharjah, United Arab Emirates