The objective of the study is to assess the safety and efficacy of the R-One device in elective Percutaneous Coronary intervention.
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Co-Primary Endpoints:
Safety Endpoint:
1. For R-One performed PCI, absence of intra-procedural complications defined
as coronary dissection * NHLBI type D, perforation, decrease of TIMI flow (*2),
acute occlusion, visible thrombus formation, significant air embolus during the
procedure, traumatic aortic or left main dissection by guiding catheter.
Efficacy Endpoint:
2. 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
Secondary Endpoints:
* Individual components of the co-primary endpoints
* Procedure duration
* Robot duration
* Radiation exposure for the patient
* Radiation exposure for the operator
* Contrast volume
* Bleeding or vascular complications at discharge
* Device Oriented composite criteria (ARC 2 definition) defined as
cardiovascular death, myocardial infarction (periprocedural and spontaneous)
non-clearly attributed to a non-target or clinically driven target lesion
revascularization
- At hospital discharge
- At 30 days (defined as cardiovascular death, MI and target lesion
revascularization)
Background summary
Coronary artery disease (CAD) is a major cause of premature death worldwide.
Treatment goals for patients with CAD are an improvement in survival and a
reduction in the risk of myocardial infarction (MI) and symptoms of coronary
disease.
Percutaneous coronary intervention (PCI) with stent implantation of obstructive
coronary lesions that causes ischemia can improve a patient's functional status
and outcome.
In recent years, robotic surgery has found applications in vascular surgery,
which can potentially reduce the limitations of current endovascular
techniques. Robotic cardiac surgery started in 1997. Now, different types of
computer-assisted surgical systems can be used for pre-operative planning,
surgical navigation and to assist in performing procedures.
For catheter-based vascular application, surgeons often insert a catheter and a
guidewire into the formal vein and artery, by which the catheter and guidewire
reach the target treatment position through handling them by a way of turning
or pushing or other movements to carry out various kinds of treatments under
X-rayed exposure and navigation. Although many protective devices have been
adopted, prolonged exposure and a high volume of operations for interventional
cardiologists result in radiation injuries. One of the most important benefits
of catheter-based robotic systems for assisting vascular interventions for both
medical staff and patients is the reduced radiation exposure that they allow.
R-One* system is a new Robot post-market CE available to interventional
cardiologists for performing PCI without changing the treatment of the
pathology. R-evolution is a post-market clinical follow up for R-One*
Study objective
The objective of the study is to assess the safety and efficacy of the R-One
device in elective Percutaneous Coronary intervention.
Study design
R-evolution, is a prospective, multicentre single-arm clinical study on a
CE-marked medical device.
Study burden and risks
R-One* is an effective tool assisting interventional cardiologist during PCI.
The system allows devices to be manipulated in the same way as with manual
interventions.
Due to the equivalence of the design of R-One* to the available equivalent
commercialized device, the clinical risks associated with R-One* are considered
to be the same as for the existing system:
Risks:
-The unintended motion of the interventional devices (guidewire or
stent/balloon catheter/ guide catheter) that may cause vessel dissection or
perforation
-Failure to accurately position catheter tip, that can increase the
intervention time and radiation exposure.
-Contamination - system components in contact with catheters and guidewires,
causing infection
-Particulate release that can cause embolization
Clinical benefits:
The use of R-One* is expected to provide the following potential benefits:
-Reduction of the interventional cardiologists* X-Ray exposure
-Ergonomic position for the interventional cardiologists
-Interventional cardiologist*s ability to manipulate instruments enhancement
allowing more precise positioning of guidewires, catheters, balloons and
stents.
rue Marie Curie 19
Rouen 76000
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Listed location countries
Age
Inclusion criteria
1. Age *18 years;
2. Candidate for PCI;
3. Presence of a de novo coronary artery stenosis of * 50% and <100% in a
native coronary artery indicated and suitable for stent implantation;
4. The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
5. The target lesion length allows for treatment with a single stent up to 38
mm in length;
6. 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);
7. 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.
Patients with complex coronary artery disease may be considered for the study.
Complex lesions such as defined below which are to be treated with PCI should
be successfully treated before the target lesion (s) in a different procedure.
Exclusion criteria
Subject will not be included if any one of the following conditions exists:
1. Target lesion has TIMI flow < 3;
2. Treatment of in-stent restenosis, or prior stent in the target vessel
proximal to the target lesion;
3. More than one target lesion per vessel requiring treatment at the time of
procedure;
4. 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;
5. Target lesion is located in left main coronary artery, or any left main
stenosis > 30%;
6. Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
7. Severe vessel tortuosity;
8. Severe vessel calcification;
9. STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of
the procedure;
10. Presence of visible thrombus;
11. Need for any procedure other than balloon angioplasty or stenting (e.g.
atherectomy, laser, are excluded);
12. Patients under judicial protection, tutorship or curatorship (for France
only);
13. 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;
14. Pregnant and breastfeeding women or intention to become pregnant prior to
completion of all follow-up procedures.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL69557.100.19 |