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NCT04573660Recruiting

Abbott Vascular Medical Device Registry

Abbott Medical Devices

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

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.

Interventions

DEVICE

Coronary and peripheral stents

DEVICE

Pacing catheters

DEVICE

Vascular plugs

DEVICE

Measurement and imaging (FFR and OCT)

DEVICE

Peripheral dilatation catheters

DEVICE

Coronary dilatation catheters

DEVICE

Coronary and peripheral guidewires

DEVICE

Vessel closure/compression devices

DEVICE

Vascular access introducers

Interested in This Trial?

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Conditions

Acute Myocardial InfarctionRestenoses, CoronaryCoronary Artery LesionsVenous EmbolismArterial Embolism

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