Clinical trial NCT05853419: Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Official title: Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Disease
Lead sponsor: Robocath
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2023-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease and a clinical indication for PCI

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical success
timeFrame: From Day 0 to Day 3
measure: Technical success
timeFrame: During procedure
Secondary outcomes:
measure: Radiation exposure for the patient
timeFrame: During procedure
measure: Overall Procedure Time
timeFrame: During procedure
measure: Overall contrast volume
timeFrame: During procedure
measure: Radiation exposure for the operator
timeFrame: During procedure
measure: Fluoroscopy Time
timeFrame: During procedure
measure: Safety event occurrence
timeFrame: From Day 0 to Day 3
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Het Ziekenhuisnetwerk Antwerpen vzw
city: Brest
country: France
facility: Brest university hospital
state: Bretagne
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
state: Ile De France
city: Rouen
country: France
facility: Rouen university hospital
city: Neuss
country: Germany
facility: Rheinland Klinikum Neuss GmbH
state: Lukaskrankenhaus
city: San Donato Milanese
country: Italy
facility: San Donato Policlinco Kardia
state: MI
city: Warsaw
country: Poland
facility: Polskie Towarzystwo Kardiologiczne
state: Par Défaut
city: Cape Town
country: South Africa
facility: Netcare Christiaan Barnard Memorial Hospital
state: Le Cap
Study officials:
affiliation: Het Ziekenhuisnetwerk Antwerpen vzw
name: Stefan Verheye, Prof.MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheinland Klinikum Neuss GmbH
name: Michael Haude, Prof.MD
role: PRINCIPAL_INVESTIGATOR
References: