Abbott Vascular Medical Device Registry

NCT ID: NCT04573660

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3784 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-25

Study Completion Date

2031-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction Restenoses, Coronary Coronary Artery Lesions Venous Embolism Arterial Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary and peripheral stents

Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents

Coronary and peripheral stents

Intervention Type DEVICE

The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents

Pacing catheters

Participants in the Pacing catheters arm will receive Pacing catheters

Pacing catheters

Intervention Type DEVICE

The participants in the Pacing catheters arm will receive Pacing catheters

Vascular plugs

Participants in the Vascular plugs arm will receive Vascular plugs

Vascular plugs

Intervention Type DEVICE

The participants in the Vascular plugs arm will receive Vascular plugs

Measurement and imaging (FFR and OCT)

Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)

Measurement and imaging (FFR and OCT)

Intervention Type DEVICE

The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)

Peripheral dilatation catheters

Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters

Peripheral dilatation catheters

Intervention Type DEVICE

The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters

Coronary dilatation catheters

Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters

Coronary dilatation catheters

Intervention Type DEVICE

The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters

Coronary and peripheral guidewires

Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires

Coronary and peripheral guidewires

Intervention Type DEVICE

The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires

Vessel closure/compression devices

Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices

Vessel closure/compression devices

Intervention Type DEVICE

The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices

Vascular access introducers

Participants in the Vascular access introducers devices arm will receive Vascular access introducers

Vascular access introducers

Intervention Type DEVICE

The participants in the Vascular access introducers arm will receive Vascular access introducers

Interventions

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Coronary and peripheral stents

The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents

Intervention Type DEVICE

Pacing catheters

The participants in the Pacing catheters arm will receive Pacing catheters

Intervention Type DEVICE

Vascular plugs

The participants in the Vascular plugs arm will receive Vascular plugs

Intervention Type DEVICE

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)

Intervention Type DEVICE

Peripheral dilatation catheters

The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters

Intervention Type DEVICE

Coronary dilatation catheters

The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters

Intervention Type DEVICE

Coronary and peripheral guidewires

The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires

Intervention Type DEVICE

Vessel closure/compression devices

The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices

Intervention Type DEVICE

Vascular access introducers

The participants in the Vascular access introducers arm will receive Vascular access introducers

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chananit Hutson, PhD

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

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University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Site Status RECRUITING

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Bryan Heart

Lincoln, Nebraska, United States

Site Status RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Site Status RECRUITING

Perth Institute of Vascular Research

Nedlands, WAUS, Australia

Site Status RECRUITING

Sir Charles Gairdner Hospital

Nedlands, WAUS, Australia

Site Status RECRUITING

Universitätsklinik Graz

Graz, Styria, Austria

Site Status RECRUITING

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, Belgium

Site Status RECRUITING

AZ Sint-Blasius Ziekenhuis

Dendermonde, Eflndrs, Belgium

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejian, China

Site Status RECRUITING

Ningbo First Hospital

Ningbo, Zhejian, China

Site Status RECRUITING

CH Chartres

Chartres, Centre-Val de Loire, France

Site Status RECRUITING

Hôpital Paris Saint-Joseph

Paris, Ile, France

Site Status COMPLETED

Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, Germany

Site Status RECRUITING

Universitätsklinikum Leipzig AÖR

Leipzig, Saxony, Germany

Site Status RECRUITING

Herz- u. Gefäßzentrum Bad Bevensen

Bad Bevensen, Saxon, Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schlesw, Germany

Site Status RECRUITING

Semmelweis University

Budapest, Budapest, Hungary

Site Status RECRUITING

Ospedale San Raffaele

Milan, Lombard, Italy

Site Status COMPLETED

Centro Cardiologico Monzino

Milan, Lombard, Italy

Site Status RECRUITING

Policlinico San Donato

San Donato Milanese, Lombard, Italy

Site Status RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Site Status COMPLETED

Hospital Universitari Vall d'Hebron

Barcelona, Catalon, Spain

Site Status RECRUITING

Hospital Universitario de la Paz

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital General Universitario de Alicante

Alicante, Valncia, Spain

Site Status RECRUITING

Kantonsspital Aarau

Aarau, Basel, Switzerland

Site Status RECRUITING

Inselspital - University Hospital of Bern

Bern, Canton of Bern, Switzerland

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, Mtaiwan, Taiwan

Site Status RECRUITING

Cathay General Hospital

Taipei, Ntaiwan, Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan City, Staiwan, Taiwan

Site Status RECRUITING

Chi Mei Hospital

Tainan City, Staiwan, Taiwan

Site Status RECRUITING

Al Qassimi Hospital

Sharjah city, Ash Shāriqah, United Arab Emirates

Site Status RECRUITING

Countries

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United States Australia Austria Belgium China France Germany Hungary Italy Netherlands Spain Switzerland Taiwan United Arab Emirates

Central Contacts

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Sharan Dhanjal, MPH

Role: CONTACT

+1 714-926-8292

Chinedu Agbonghai, MS

Role: CONTACT

Facility Contacts

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Francesco Bedogni, MD

Role: primary

Other Identifiers

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ABT-CIP-10349

Identifier Type: -

Identifier Source: org_study_id

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