Evaluating a robotic system for coronary angioplasty procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CHANGE registry aims to assess the real-world performance and safety of the R-One robotic system during Percutaneous Coronary Intervention (PCI) for patients with coronary artery disease. This observational study will involve 500 patients across up to 15 centers in Europe and South Africa, utilizing the R-One system to assist in the delivery and manipulation of coronary guidewires and stent/balloon devices. The R-One system is not autonomous and operates under the direct commands of the operator, ensuring controlled intervention. The study will provide valuable data on the clinical benefits and safety profile of this innovative technology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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.

Where it's running

• Het Ziekenhuisnetwerk Antwerpen vzw
  Antwerp, Belgium Recruiting
• Brest university hospital
  Brest, Brittany Region, France Recruiting
• Rouen university hospital
  Rouen, France Recruiting
• Centre Cardiologique du Nord
  Saint-Denis, Île-de-France Region, France Recruiting
• Rheinland Klinikum Neuss GmbH
  Neuss, Lukaskrankenhaus, Germany Recruiting
• San Donato Policlinco Kardia
  San Donato Milanese, Mi, Italy Not yet recruiting

Study contacts

• Principal investigator: Stefan Verheye, Prof.MD — Het Ziekenhuisnetwerk Antwerpen vzw
• Study coordinator: Hamouda Abassi, PhD
• Email: hamouda.abassi@robocath.com
• Phone: +33 2 32 10 67 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.