R-One Efficiency For PCI Evolution With Robotic Assistance

Coronary Artery Disease Clinical Trial

— R-EVOLUTION  

Official title:

R-One Efficiency For PCI Evolution With Robotic Assistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163393
• Other study ID #: ROB-01
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2022
• Source: Robocath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 15, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years;
• Candidate for PCI;
• Presence of a de novo coronary artery stenosis of = 50% and <100% in a native coronary artery indicated and suitable for stent implantation;
• The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
• The target lesion length allows for treatment with a single stent up to 38 mm in length;
• Up to 2 target vessels each with a single target lesion requiring a single stent per lesion and treatable within a single procedure may be included (no further staged procedure allowed);
• The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.

Exclusion Criteria:

• Target lesion has TIMI flow < 3;
• Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
• More than one target lesion per vessel requiring treatment at the time of procedure;
• Target lesion is a bifurcation requiring balloon or stent implantation of the side branch, with a side-branch RVD of =1.5 mm with a DS =50% at or within 5 mm its origin, or RVD =2.0 mm regardless of the presence of side branch disease;
• Target lesion is located in left main coronary artery, or any left main stenosis > 30%;
• Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
• Severe vessel tortuosity;
• Severe vessel calcification;
• STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of the procedure;
• Presence of visible thrombus;
• Need for any procedure other than balloon angioplasty or stenting (e.g. atherectomy, laser, are excluded);
• Patients under judicial protection, tutorship or curatorship (for France only);
• Any patient participating in another clinical study evaluating a drug or a medical device (except registries for which the primary endpoint has not been evaluated;
• Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Procedure:
• Percutaneous Coronary Intervention
PCI with robotic assistance

Device:
• Percutaneous Coronary Intervention using R-One assistance
PCI with robotic assistance

Locations

Country	Name	City	State
Belgium	Het Ziekenhuisnetwerk Antwerpen vzw	Antwerpen
France	CHU Caen Normandie	Caen
France	CHU Rouen	Rouen
France	Clinique Pasteur	Toulouse
Luxembourg	INCCI	Luxembourg
Netherlands	Maastad Ziekenhuis	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Robocath

Countries where clinical trial is conducted

Belgium,  France,  Luxembourg,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)	Absence of Intra-procedural complications (Dissection >/= NHLBI type D, perforation, decrease of TIMI flow (	Peri-procedure
Primary	Efficacy Endpoint: Number of Patients with Procedure technical success	Procedure technical success defined as the successful advancement and retraction of all PCI devices (guidewires, balloon catheters and stents) and the successful treatment of all the target lesions using the R-One system and without conversion to manual operation	During Procedure
Secondary	Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)	Component of the Primary Safety Endpoint: Absence of Intra-procedural complications (Dissection >/= NHLBI type D, perforation, decrease of TIMI flow (	During Procedure
Secondary	Procedure duration	Time between arterial sheath introduction and sheath removal	During Procedure
Secondary	Robot duration	From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed	During Procedure
Secondary	Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)	Patient and Operator	During Procedure
Secondary	Contrast Volume in mL	Measure of the volume of injected contrast media	During Procedure
Secondary	Rate of Bleeding or Vascular Complications	BARC definition	Up to 1 month
Secondary	Rate of Device Oriented Composite Criteria (Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization)	ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization	Post-Procedure, 1 month