R-One Efficiency For PCI Evolution with robotic assistance
- Conditions
- coronary artery disease10011082
- Registration Number
- NL-OMON55644
- Lead Sponsor
- Robocath
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Co-Primary Endpoints:<br /><br><br /><br>Safety Endpoint:<br /><br>1. For R-One performed PCI, absence of intra-procedural complications defined<br /><br>as coronary dissection * NHLBI type D, perforation, decrease of TIMI flow (*2),<br /><br>acute occlusion, visible thrombus formation, significant air embolus during the<br /><br>procedure, traumatic aortic or left main dissection by guiding catheter.<br /><br><br /><br>Efficacy Endpoint:<br /><br>2. Procedure technical success, defined as the successful advancement and<br /><br>retraction of all PCI devices (guidewires, balloon catheters and stents) and<br /><br>the successful treatment of all the target lesions using the R-One System and<br /><br>without conversion to manual operation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints:<br /><br><br /><br>* Individual components of the co-primary endpoints<br /><br>* Procedure duration<br /><br>* Robot duration<br /><br>* Radiation exposure for the patient<br /><br>* Radiation exposure for the operator<br /><br>* Contrast volume<br /><br>* Bleeding or vascular complications at discharge<br /><br>* Device Oriented composite criteria (ARC 2 definition) defined as<br /><br>cardiovascular death, myocardial infarction (periprocedural and spontaneous)<br /><br>non-clearly attributed to a non-target or clinically driven target lesion<br /><br>revascularization<br /><br>- At hospital discharge<br /><br>- At 30 days (defined as cardiovascular death, MI and target lesion<br /><br>revascularization) </p><br>