Recruiting NCT04573660

Abbott Vascular Medical Device Registry

— Observational Acute Myocardial Infarction Restenoses, Coronary Coronary Artery Lesions Venous Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Coronary and peripheral stents, Pacing catheters, Vascular plugs, Measurement and imaging (FFR and OCT).
Who it may be relevant to: Registry conditions: Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, China +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

Device Coronary and peripheral stents
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Device Pacing catheters
The participants in the Pacing catheters arm will receive Pacing catheters
Device Vascular plugs
The participants in the Vascular plugs arm will receive Vascular plugs
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)
Device Peripheral dilatation catheters
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
Device Coronary dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Device Coronary and peripheral guidewires
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
Device Vessel closure/compression devices
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
Device Vascular access introducers
The participants in the Vascular access introducers arm will receive Vascular access introducers

Primary outcome measures

Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)]
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [Time frame: 30 days]
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [Time frame: 12 months]
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)]
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [Time frame: 30 days]
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [Time frame: 12 months]
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR [Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)]
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR [Time frame: 30 days]
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR [Time frame: 12 months]
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) [Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)]

Eligibility criteria

Inclusion criteria

Subject is at least 18 years of age.
Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 7 centers

University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham
Arkansas Heart Hospital — Little Rock
Kaiser Permanente Los Angeles Medical Center — Los Angeles
Northwestern Memorial Hospital — Chicago
Bryan Heart — Lincoln
Ohio State University — Columbus
Wellmont CVA Heart Institute — Kingsport

Germany · 5 centers

Cardioangiologisches Centrum am Bethanien Krankenhaus — Frankfurt am Main
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz — Mainz
Universitätsklinikum Leipzig AÖR — Leipzig
Herz- u. Gefäßzentrum Bad Bevensen — Bad Bevensen
Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel

Taiwan · 4 centers

Taichung Veterans General Hospital — Taichung
Cathay General Hospital — Taipei
National Cheng Kung University Hospital — Tainan
Chi Mei Hospital — Tainan

China · 3 centers

The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Jinhua Municipal Central Hospital — Jinhua
Ningbo First Hospital — Ningbo

Italy · 3 centers

Ospedale San Raffaele — Milan
Centro Cardiologico Monzino — Milan
Policlinico San Donato — San Donato Milanese

Spain · 3 centers

Hospital Universitari Vall d'Hebron — Barcelona
Hospital Universitario de la Paz — Madrid
Hospital General Universitario de Alicante — Alicante

Australia · 2 centers

Perth Institute of Vascular Research — Nedlands
Sir Charles Gairdner Hospital — Nedlands

Belgium · 2 centers

Onze-Lieve-Vrouwziekenhuis Campus Aalst — Aalst
AZ Sint-Blasius Ziekenhuis — Dendermonde

France · 2 centers

CH Chartres — Chartres
Hôpital Paris Saint-Joseph — Paris

Switzerland · 2 centers

Kantonsspital Aarau — Aarau
Inselspital - University Hospital of Bern — Bern

Austria · 1 center

Universitätsklinik Graz — Graz

Hungary · 1 center

Semmelweis University — Budapest

Netherlands · 1 center

St. Antonius Ziekenhuis — Nieuwegein

United Arab Emirates · 1 center

Al Qassimi Hospital — Sharjah city

Identifiers

NCT: NCT04573660 · ABT-CIP-10349

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗