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Clinical Trials in Germany / NCT05853419
Recruiting Observational

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

NCT05853419 · tracked via the Priya Life Science Germany tracker
Sponsor
Robocath
Phase
Observational
Started
2023-06-20
Last updated
2025-08-20

Condition(s) studied

Coronary Disease

Investigational drug(s) / intervention(s)

Robotic-assisted PCI

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical success — From Day 0 to Day 3
    Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse cardiac events (MACE).
  • Technical success — During procedure
    Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion

Trial sites (8)

FacilityCityRegionStatus
Het Ziekenhuisnetwerk Antwerpen vzw Antwerp Belgium Recruiting
Brest university hospital Brest Brittany Region Recruiting
Rouen university hospital Rouen France Recruiting
Centre Cardiologique du Nord Saint-Denis Île-de-France Region Recruiting
Rheinland Klinikum Neuss GmbH Neuss Lukaskrankenhaus Recruiting
San Donato Policlinco Kardia San Donato Milanese MI Not Yet Recruiting
Polskie Towarzystwo Kardiologiczne Warsaw Par Défaut Not Yet Recruiting
Netcare Christiaan Barnard Memorial Hospital Cape Town le Cap Not Yet Recruiting

Other trials for the same condition

The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries Active, not recruiting
Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05853419 on ClinicalTrials.gov ↗ ← All trials in Germany