Evaluating a robotic system for coronary angioplasty procedures
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
This study is testing a new robotic system to see if it can safely help doctors perform heart procedures for patients with blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Robocath Industry-sponsored |
| Locations | 8 sites (Antwerp and 7 other locations) |
| Trial ID | NCT05853419 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with coronary artery disease who are clinically indicated for robotic-assisted PCI.
Not a fit: Patients experiencing STEMI or cardiogenic shock, or those deemed unsuitable for robotic-assisted PCI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of PCI procedures for patients with coronary artery disease.
How similar studies have performed: While robotic-assisted PCI is a developing field, this specific approach with the R-One system is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Antwerp and 7 other locations
- 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)
- Polskie Towarzystwo Kardiologiczne — Warsaw, Par Défaut, Poland (Not_yet_recruiting)
- Netcare Christiaan Barnard Memorial Hospital — Cape Town, le Cap, South Africa (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.