Change History and Adopt a Robotic SolutioN for anGioplasty procedurE (CHANGE)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Disease
• Intervention / Treatment: Device: Robotic-assisted 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Hamouda Abassi, PhD; Phone Number: +33 2 32 10 67 42; Email: hamouda.abassi@robocath.com

Study Locations

• Belgium
  • Antwerpen, Belgium, 2000
    • Recruiting
    • Het Ziekenhuisnetwerk Antwerpen vzw
    • Principal Investigator: Stefan Verheye, Prof.MD
    • Contact: Stefan Verheye, Prof.MD
• France
  • Rouen, France, 76000
    • Recruiting
    • Rouen university hospital
    • Principal Investigator: Eric Durand, Prof.MD
    • Contact: Eric Durand, Prof.MD
  • Bretagne
    • Brest, Bretagne, France, 29609
      • Recruiting
      • Brest University Hospital
      • Principal Investigator: Romain DIDIER, Prof.MD
      • Contact: Romain Didier, Prof. MD
  • Ile De France
    • Saint-Denis, Ile De France, France, 93200
      • Recruiting
      • Centre Cardiologique du Nord
      • Principal Investigator: Mohammed NEJJARI, MD
      • Sub-Investigator: Franck Digne, MD
      • Contact: Mohamed Nejjari, MD
• Germany
  • Lukaskrankenhaus
    • Neuss, Lukaskrankenhaus, Germany, 41464
      • Recruiting
      • Rheinland Klinikum Neuss GmbH
      • Principal Investigator: Michael HAUDE, Prof.MD
      • Contact: Michael Haude, Prof.MD
• Italy
  • MI
    • San Donato Milanese, MI, Italy, 20097
      • Not yet recruiting
      • San Donato Policlinco Kardia
      • Contact: Francesco BEDOGNI
      • Principal Investigator: Francesco BEDOGNI, MD
• Poland
  • Par Défaut
    • Warsaw, Par Défaut, Poland, 02-507
      • Not yet recruiting
      • Polskie Towarzystwo Kardiologiczne
      • Principal Investigator: Robert J GIL, Prof.MD
      • Contact: Robert J Gil
• South Africa
  • Le Cap
    • Cape Town, Le Cap, South Africa, 8001
      • Not yet recruiting
      • Netcare Christiaan Barnard Memorial Hospital
      • Principal Investigator: Faizel LORGAT, MD
      • Contact: Faizel Lorgat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease and a clinical indication for PCI

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; Adult patients with coronary artery disease and a clinical indication for PCI	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From Day 0 to Day 3
Technical success	Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	During procedure
Fluoroscopy Time	Total fluoroscopy utilized during the procedure as recorded by an Imaging System.	During procedure
Radiation exposure for the patient	Dose (DSP and Air Kerma) measured by the imaging system during the procedure.	During procedure
Overall contrast volume	Total volume of contrast (mL) used during the procedure.	During procedure
Radiation exposure for the operator	Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.	During procedure
Safety event occurrence	Medical device's safety event occurrence	From Day 0 to Day 3

Collaborators and Investigators

• Sponsor: Robocath
• Collaborators: European Cardiovascular Research Center
• 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): June 20, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: ROB-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No