- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05853419
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE (CHANGE)
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hamouda Abassi, PhD
- Phone Number: +33 2 32 10 67 42
- Email: hamouda.abassi@robocath.com
Study Locations
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Antwerpen, Belgium, 2000
- Recruiting
- Het Ziekenhuisnetwerk Antwerpen vzw
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Principal Investigator:
- Stefan Verheye, Prof.MD
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Contact:
- Stefan Verheye, Prof.MD
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Rouen, France, 76000
- Recruiting
- Rouen university hospital
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Principal Investigator:
- Eric Durand, Prof.MD
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Contact:
- Eric Durand, Prof.MD
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Bretagne
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Brest, Bretagne, France, 29609
- Recruiting
- Brest University Hospital
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Principal Investigator:
- Romain DIDIER, Prof.MD
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Contact:
- Romain Didier, Prof. MD
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Ile De France
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Saint-Denis, Ile De France, France, 93200
- Recruiting
- Centre Cardiologique du Nord
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Principal Investigator:
- Mohammed NEJJARI, MD
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Sub-Investigator:
- Franck Digne, MD
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Contact:
- Mohamed Nejjari, MD
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Lukaskrankenhaus
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Neuss, Lukaskrankenhaus, Germany, 41464
- Recruiting
- Rheinland Klinikum Neuss GmbH
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Principal Investigator:
- Michael HAUDE, Prof.MD
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Contact:
- Michael Haude, Prof.MD
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MI
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San Donato Milanese, MI, Italy, 20097
- Not yet recruiting
- San Donato Policlinco Kardia
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Contact:
- Francesco BEDOGNI
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Principal Investigator:
- Francesco BEDOGNI, MD
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Par Défaut
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Warsaw, Par Défaut, Poland, 02-507
- Not yet recruiting
- Polskie Towarzystwo Kardiologiczne
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Principal Investigator:
- Robert J GIL, Prof.MD
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Contact:
- Robert J Gil
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Le Cap
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Cape Town, Le Cap, South Africa, 8001
- Not yet recruiting
- Netcare Christiaan Barnard Memorial Hospital
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Principal Investigator:
- Faizel LORGAT, MD
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Contact:
- Faizel Lorgat, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study population
Adult patients with coronary artery disease and a clinical indication for PCI
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical success
Time Frame: From Day 0 to Day 3
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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).
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From Day 0 to Day 3
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Technical success
Time Frame: During procedure
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Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion
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During procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Procedure Time
Time Frame: During procedure
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Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
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During procedure
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Fluoroscopy Time
Time Frame: During procedure
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Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
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During procedure
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Radiation exposure for the patient
Time Frame: During procedure
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Dose (DSP and Air Kerma) measured by the imaging system during the procedure.
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During procedure
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Overall contrast volume
Time Frame: During procedure
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Total volume of contrast (mL) used during the procedure.
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During procedure
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Radiation exposure for the operator
Time Frame: During procedure
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Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.
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During procedure
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Safety event occurrence
Time Frame: From Day 0 to Day 3
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Medical device's safety event occurrence
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From Day 0 to Day 3
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stefan Verheye, Prof.MD, Het Ziekenhuisnetwerk Antwerpen vzw
- Principal Investigator: Michael Haude, Prof.MD, Rheinland Klinikum Neuss GmbH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROB-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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