Coronary DiseaseCHANGENCT05853419
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
An observational study of Coronary Disease, run by Robocath at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Robotic-assisted PCI
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 20 Jun 2023to Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with coronary artery disease and a clinical indication for PCI
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
France3 sites, 3 recruiting
- Recruiting
Brest university hospital
Brest, Brittany Region, 29609
Romain Didier, Prof. MD
Romain DIDIER, Prof.MD
- Recruiting
Rouen university hospital
Rouen, 76000
Eric Durand, Prof.MD
Eric Durand, Prof.MD
- Recruiting
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, 93200
Mohamed Nejjari, MD
Mohammed NEJJARI, MD
Belgium1 site, 1 recruiting
- Recruiting
Het Ziekenhuisnetwerk Antwerpen vzw
Antwerp, 2000
Stefan Verheye, Prof.MD
Stefan Verheye, Prof.MD
Germany1 site, 1 recruiting
- Recruiting
Rheinland Klinikum Neuss GmbH
Neuss, Lukaskrankenhaus, 41464
Michael Haude, Prof.MD
Michael HAUDE, Prof.MD
Italy1 site, 1 recruiting
- Not yet recruiting
San Donato Policlinco Kardia
San Donato Milanese, MI, 20097
Francesco BEDOGNI
Francesco BEDOGNI, MD
Poland1 site, 1 recruiting
- Not yet recruiting
Polskie Towarzystwo Kardiologiczne
Warsaw, Par Défaut, 02-507
Robert J Gil
Robert J GIL, Prof.MD
South Africa1 site, 1 recruiting
- Not yet recruiting
Netcare Christiaan Barnard Memorial Hospital
Cape Town, le Cap, 8001
Faizel Lorgat, MD
Faizel LORGAT, MD
About this study
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.
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Robotic-assisted PCI
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted PCIDevice
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 group | Role | What they receive |
|---|---|---|
| Study population | Adult patients with coronary artery disease and a clinical indication for PCI Receives: Device: Robotic-assisted PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
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).
Measured: From Day 0 to Day 3
Technical success
Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion
Measured: During procedure
Secondary outcomes (6)
Radiation exposure for the patient
Dose (DSP and Air Kerma) measured by the imaging system during the procedure.
Measured: During procedure
Overall Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Measured: During procedure
Overall contrast volume
Total volume of contrast (mL) used during the procedure.
Measured: During procedure
Radiation exposure for the operator
Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.
Measured: During procedure
Fluoroscopy Time
Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
Measured: During procedure
Safety event occurrence
Medical device's safety event occurrence
Measured: From Day 0 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start20 Jun 2023
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Robocath
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Stefan Verheye, Prof.MD, Principal investigator, Het Ziekenhuisnetwerk Antwerpen vzwMichael Haude, Prof.MD, Principal investigator, Rheinland Klinikum Neuss GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853419
- Sponsor's protocol ID
- ROB-03
- Acronym
- CHANGE
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
- ClinicalTrials.gov ID
- NCT05853419
- Acronym / sponsor ID
- CHANGE / ROB-03
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RobocathIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Device: Robotic-assisted PCIAdult patients with coronary artery disease and a clinical indication for PCI |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with coronary artery disease and a clinical indication for PCI
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted PCIRobotic-assisted PCI will be performed according to the routine hospital practices, current scientific guidelines and following Instructions for Use (IFU) provided by the manufacturer | Device | Study population |
Primary outcome
Clinical success
Time frame: 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
Time frame: During procedure
Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Verheye, Prof.MD principal investigator
Het Ziekenhuisnetwerk Antwerpen vzw
Michael Haude, Prof.MD principal investigator
Rheinland Klinikum Neuss GmbH
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Robocath at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium, Germany, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamouda Abassi, PhD (+33 2 32 10 67 42, hamouda.abassi@robocath.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: From Day 0 to Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.