Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Coronary Disease Clinical Trial

— CHANGE  

Official title:

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853419
• Other study ID #: ROB-03
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2023
• Source: Robocath
• Contact: Hamouda Abassi, PhD
• Phone: +33 2 32 10 67 42
• Email: hamouda.abassi[@]robocath.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

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

Locations

Country	Name	City	State
Belgium	Het Ziekenhuisnetwerk Antwerpen vzw	Antwerpen
France	Brest university hospital	Brest	Bretagne
France	Rouen university hospital	Rouen
France	Centre Cardiologique du Nord	Saint-Denis	Ile De France
Germany	Rheinland Klinikum Neuss GmbH	Neuss	Lukaskrankenhaus
Italy	San Donato Policlinco Kardia	San Donato Milanese	MI
Poland	Polskie Towarzystwo Kardiologiczne	Warsaw	Par Défaut
South Africa	Netcare Christiaan Barnard Memorial Hospital	Cape Town	Le Cap

Sponsors (2)

Lead Sponsor	Collaborator
Robocath	European Cardiovascular Research Center

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Technical success	Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion	During procedure
Secondary	Radiation exposure for the patient	Dose (DSP and Air Kerma) measured by the imaging system during the procedure.	During procedure
Secondary	Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	During procedure
Secondary	Overall contrast volume	Total volume of contrast (mL) used during the procedure.	During procedure
Secondary	Radiation exposure for the operator	Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.	During procedure
Secondary	Fluoroscopy Time	Total fluoroscopy utilized during the procedure as recorded by an Imaging System.	During procedure
Secondary	Safety event occurrence	Medical device's safety event occurrence	From Day 0 to Day 3