Coronary Disease
Conditions
Brief 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.
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.
Interventions
DEVICERobotic-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
Sponsors
European Cardiovascular Research Center
Robocath
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 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 | During procedure | Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall contrast volume | During procedure | Total volume of contrast (mL) used during the procedure. |
| Radiation exposure for the operator | During procedure | Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure. |
| Radiation exposure for the patient | During procedure | Dose (DSP and Air Kerma) measured by the imaging system during the procedure. |
| Safety event occurrence | From Day 0 to Day 3 | Medical device's safety event occurrence |
| Fluoroscopy Time | During procedure | Total fluoroscopy utilized during the procedure as recorded by an Imaging System. |
| Overall Procedure Time | During procedure | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
Countries
Belgium, France, Germany, Italy, Poland, South Africa
Contacts
Primary ContactHamouda Abassi, PhD
Outcome results
None listed