Abbott Vascular Medical Device Registry

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [Срок оценки: 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) [Срок оценки: 30 days]
• Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [Срок оценки: 12 months]
• Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [Срок оценки: 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 [Срок оценки: 30 days]
• Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 30 days]
• Peripheral Stents (Renal Indication) - Number of participants with composite of TLR [Срок оценки: 12 months]
• Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 7 центров

• 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

Германия · 5 центров

• 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

Тайвань · 4 центра

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

Китай · 3 центра

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

Италия · 3 центра

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

Испания · 3 центра

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

Австралия · 2 центра

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

Бельгия · 2 центра

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

Франция · 2 центра

• CH Chartres — Chartres
• Hôpital Paris Saint-Joseph — Paris

Швейцария · 2 центра

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

Австрия · 1 центр

• Universitätsklinik Graz — Graz

Венгрия · 1 центр

• Semmelweis University — Budapest

Нидерланды · 1 центр

• St. Antonius Ziekenhuis — Nieuwegein

ОАЭ · 1 центр

• Al Qassimi Hospital — Sharjah city

Идентификаторы

NCT: NCT04573660 · ABT-CIP-10349

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗