Abbott Vascular Medical Device Registry
Start Date
10/25/2020
Completion Date
11/1/2031
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Coronary and peripheral stents
Pacing catheters
Vascular plugs
Measurement and imaging (FFR and OCT)
Peripheral dilatation catheters
Coronary dilatation catheters
Coronary and peripheral guidewires
Vessel closure/compression devices
Vascular access introducers
Conditions
Locations
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama 35249
United States
Arkansas Heart Hospital
Little Rock, Arkansas 72211
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Bryan Heart
Lincoln, Nebraska 68506
United States
Ohio State University
Columbus, Ohio 43210
United States
Wellmont CVA Heart Institute
Kingsport, Tennessee 37660
United States
Perth Institute of Vascular Research
Nedlands, WAUS 6009
Australia
Sir Charles Gairdner Hospital
Nedlands, WAUS 6009
Australia
Universitätsklinik Graz
Graz, Styria 8036
Austria
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst, Eflndrs 9300
Belgium
AZ Sint-Blasius Ziekenhuis
Dendermonde, Eflndrs 9200
Belgium
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
China
Jinhua Municipal Central Hospital
Jinhua, Zhejian 321000
China
Ningbo First Hospital
Ningbo, Zhejian 315000
China
CH Chartres
Chartres, Centre-Val de Loire 28018
France
Hôpital Paris Saint-Joseph
Paris, Ile 75014
France
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse 60389
Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela 55131
Germany
Universitätsklinikum Leipzig AÖR
Leipzig, Saxony 04103
Germany
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, Saxon 29549
Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schlesw 24105
Germany
Semmelweis University
Budapest, Budapest 1122
Hungary
Ospedale San Raffaele
Milan, Lombard 20132
Italy
Centro Cardiologico Monzino
Milan, Lombard 20138
Italy
Policlinico San Donato
San Donato Milanese, Lombard 20097
Italy
St. Antonius Ziekenhuis
Nieuwegein, Utrecht 3435 CM
Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Catalon 08035
Spain
Hospital Universitario de la Paz
Madrid, Madrid 28046
Spain
Hospital General Universitario de Alicante
Alicante, Valncia 03010
Spain
Kantonsspital Aarau
Aarau, Basel 5001
Switzerland
Inselspital - University Hospital of Bern
Bern, Canton of Bern 3010
Switzerland
Taichung Veterans General Hospital
Taichung, Mtaiwan 40705
Taiwan
Cathay General Hospital
Taipei, Ntaiwan 106
Taiwan
National Cheng Kung University Hospital
Tainan, Staiwan 704
Taiwan
Chi Mei Hospital
Tainan, Staiwan 710
Taiwan
Al Qassimi Hospital
Sharjah city, Emirate of Sharjah 3500
United Arab Emirates