Back to resultsR-One Efficiency For PCI Evolution With Robotic Assistance (R-EVOLUTION)
Primary Purpose
Coronary Artery Disease, Percutaneous Coronary Intervention
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention using R-One assistance
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Percutaneous Coronary Intervention
Eligibility Criteria
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.
Sites / Locations
- Het Ziekenhuisnetwerk Antwerpen vzw
- CHU Caen Normandie
- CHU Rouen
- Clinique Pasteur
- INCCI
- Maastad Ziekenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
R-One
Arm Description
Patients treated with robotic assistance
Outcomes
Primary Outcome Measures
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 (</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter
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
Secondary Outcome Measures
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 (</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter
Procedure duration
Time between arterial sheath introduction and sheath removal
Robot duration
From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
Patient and Operator
Contrast Volume in mL
Measure of the volume of injected contrast media
Rate of Bleeding or Vascular Complications
BARC definition
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04163393
Brief Title
R-One Efficiency For PCI Evolution With Robotic Assistance
Acronym
R-EVOLUTION
Official Title
R-One Efficiency For PCI Evolution With Robotic Assistance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Robocath
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Percutaneous Coronary Intervention
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
R-One
Arm Type
Experimental
Arm Description
Patients treated with robotic assistance
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
PCI with robotic assistance
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention using R-One assistance
Intervention Description
PCI with robotic assistance
Primary Outcome Measure Information:
Title
Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)
Description
Absence of Intra-procedural complications (Dissection >/= NHLBI type D, perforation, decrease of TIMI flow (</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter
Time Frame
Peri-procedure
Title
Efficacy Endpoint: Number of Patients with Procedure technical success
Description
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
Time Frame
During Procedure
Secondary Outcome Measure Information:
Title
Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)
Description
Component of the Primary Safety Endpoint: Absence of Intra-procedural complications (Dissection >/= NHLBI type D, perforation, decrease of TIMI flow (</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter
Time Frame
During Procedure
Title
Procedure duration
Description
Time between arterial sheath introduction and sheath removal
Time Frame
During Procedure
Title
Robot duration
Description
From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
Time Frame
During Procedure
Title
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
Description
Patient and Operator
Time Frame
During Procedure
Title
Contrast Volume in mL
Description
Measure of the volume of injected contrast media
Time Frame
During Procedure
Title
Rate of Bleeding or Vascular Complications
Description
BARC definition
Time Frame
Up to 1 month
Title
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)
Description
ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization
Time Frame
Post-Procedure, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Het Ziekenhuisnetwerk Antwerpen vzw
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
CHU Caen Normandie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
INCCI
City
Luxembourg
ZIP/Postal Code
L-1210
Country
Luxembourg
Facility Name
Maastad Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3079
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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R-One Efficiency For PCI Evolution With Robotic Assistance
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