CHANGE: Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Radiation exposure for the patient [During procedure]
Dose (DSP and Air Kerma) measured by the imaging system during the procedure.
- Overall Procedure Time [During procedure]
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
- 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.
- Fluoroscopy Time [During procedure]
Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
- Safety event occurrence [From Day 0 to Day 3]
Medical device's safety event occurrence
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Age ≥ 18 years;
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2.Subjects with coronary artery disease with clinical indication for PCI;
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3.Subject deemed appropriate for robotic-assisted PCI; and
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4.The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
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1.Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or
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2.The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI.
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3.STEMI
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4.Cardiogenic shock
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Het Ziekenhuisnetwerk Antwerpen vzw | Antwerpen | Belgium | 2000 | |
| 2 | BREST University hospital | Brest | Bretagne | France | 29609 |
| 3 | Centre Cardiologique du Nord | Saint-Denis | Ile De France | France | 93200 |
| 4 | Rouen university hospital | Rouen | France | 76000 | |
| 5 | Rheinland Klinikum Neuss GmbH | Neuss | Lukaskrankenhaus | Germany | 41464 |
| 6 | San Donato Policlinco Kardia | San Donato Milanese | MI | Italy | 20097 |
| 7 | Polskie Towarzystwo Kardiologiczne | Warsaw | Par Défaut | Poland | 02-507 |
| 8 | Netcare Christiaan Barnard Memorial Hospital | Cape Town | Le Cap | South Africa | 8001 |
Sponsors and Collaborators
- Robocath
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- ROB-03