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Обзор

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.

Подробное описание

The R-One system is a class "IIb" CE marked medical device designed to remote deliver and manipulate coronary guidewires and stent/balloon devices during Percutaneous Coronary Intervention (PCI). The system comprises the R-One Robotic Platform used in combination with two accessories, the Mobile Radioprotection Screen and a sterile and single-use R-One Consumable Kit. The R-One is not autonomous and operates only under the operator's commands.

This study is a single-arm, open-label, multi-center registry.

The CHANGE registry, part of the ROBOCATH's post-market clinical follow-up activities, is a real world study aiming to confirm the safety and performance, including the clinical benefit, of the R-One robotic systems medical device.

500 patients with coronary artery disease and with clinical indication for PCI will be recruited in up to Up to 15 centers distributed in Europe and South Africa.

Вмешательства

• Устройство Robotic-assisted PCI
  Robotic-assisted PCI will be performed according to the routine hospital practices, current scientific guidelines and following Instructions for Use (IFU) provided by the manufacturer

Первичные конечные точки

• Clinical success [Срок оценки: From Day 0 to Day 3]
• Technical success [Срок оценки: During procedure]

Вторичные конечные точки (6)

• Radiation exposure for the patient [Срок оценки: During procedure]
• Overall Procedure Time [Срок оценки: During procedure]
• Overall contrast volume [Срок оценки: During procedure]
• Radiation exposure for the operator [Срок оценки: During procedure]
• Fluoroscopy Time [Срок оценки: During procedure]
• Safety event occurrence [Срок оценки: From Day 0 to Day 3]

Критерии участия

Критерии включения

• 1\. Age ≥ 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 3 центра

• Brest university hospital — Brest
• Rouen university hospital — Rouen
• Centre Cardiologique du Nord — Saint-Denis

Бельгия · 1 центр

• Het Ziekenhuisnetwerk Antwerpen vzw — Antwerp

Германия · 1 центр

• Rheinland Klinikum Neuss GmbH — Neuss

Италия · 1 центр

• San Donato Policlinco Kardia — San Donato Milanese

Польша · 1 центр

• Polskie Towarzystwo Kardiologiczne — Warsaw

ЮАР · 1 центр

• Netcare Christiaan Barnard Memorial Hospital — Cape Town

Идентификаторы

NCT: NCT05853419 · ROB-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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