Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Robocath500 enrolled

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.

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

500

Conditions

Coronary Disease

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Locations (8)

Het Ziekenhuisnetwerk Antwerpen vzw

Antwerp, Belgium

RECRUITING

Brest university hospital

Brest, Brittany Region, France

RECRUITING

Rouen university hospital

Rouen, France

Outcomes

Primary Outcomes

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).

Time frame: From Day 0 to Day 3

Technical success

Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion

Time frame: During procedure

Secondary Outcomes

Radiation exposure for the patient

Dose (DSP and Air Kerma) measured by the imaging system during the procedure.

Time frame: During procedure

Overall Procedure Time

Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

Time frame: During procedure

Overall contrast volume

Total volume of contrast (mL) used during the procedure.

Time frame: During procedure

Radiation exposure for the operator

Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.

Time frame: During procedure

Fluoroscopy Time

Total fluoroscopy utilized during the procedure as recorded by an Imaging System.

Time frame: During procedure

Safety event occurrence

Medical device's safety event occurrence

Central Contacts

Hamouda Abassi, PhD

CONTACT

+33 2 32 10 67 42 hamouda.abassi@robocath.com

Data from ClinicalTrials.gov

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