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Recruiting NCT05853419

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

— Observational Coronary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic-assisted PCI.
Who it may be relevant to
Registry conditions: Coronary Disease. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France, Germany, Italy, Poland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Device 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

Primary outcome measures

  • Clinical success [Time frame: From Day 0 to Day 3]
  • Technical success [Time frame: During procedure]
Secondary outcome measures (6)
  • Radiation exposure for the patient [Time frame: During procedure]
  • Overall Procedure Time [Time frame: During procedure]
  • Overall contrast volume [Time frame: During procedure]
  • Radiation exposure for the operator [Time frame: During procedure]
  • Fluoroscopy Time [Time frame: During procedure]
  • Safety event occurrence [Time frame: From Day 0 to Day 3]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Brest university hospital — Brest
  • Rouen university hospital — Rouen
  • Centre Cardiologique du Nord — Saint-Denis
Belgium · 1 center
  • Het Ziekenhuisnetwerk Antwerpen vzw — Antwerp
Germany · 1 center
  • Rheinland Klinikum Neuss GmbH — Neuss
Italy · 1 center
  • San Donato Policlinco Kardia — San Donato Milanese
Poland · 1 center
  • Polskie Towarzystwo Kardiologiczne — Warsaw
South Africa · 1 center
  • Netcare Christiaan Barnard Memorial Hospital — Cape Town

Identifiers

NCT: NCT05853419 · ROB-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗