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โ† Trials
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Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Recruitingn/aAges 18 Years - 120 YearsAllRobocath
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In plain words

What the trial is, and whether it could suit you

The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 1\. Age โ‰ฅ 18 years; * 2.Subjects with coronary artery disease with clinical indication for PCI; * 3.Subject deemed appropriate for robotic-assisted PCI; and * 4.The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: * 1.Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or * 2.The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI. * 3.STEMI * 4.Cardiogenic shock * 5.Subjects will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
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What it tests

  • Robotic-assisted PCI
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Where

8 sites
Het Ziekenhuisnetwerk Antwerpen vzw
Antwerp, Belgium
Brest university hospital
Brest, France
Rouen university hospital
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, France
Rheinland Klinikum Neuss GmbH
Neuss, Germany
San Donato Policlinco Kardia
San Donato Milanese, Italy
Polskie Towarzystwo Kardiologiczne
Warsaw, Poland
Netcare Christiaan Barnard Memorial Hospital
Cape Town, South Africa
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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