Clinical trial NCT04163393: R-One Efficiency For PCI Evolution With Robotic Assistance
Official title: R-One Efficiency For PCI Evolution With Robotic Assistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Robocath
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)
timeFrame: Peri-procedure
measure: Efficacy Endpoint: Number of Patients with Procedure technical success
timeFrame: During Procedure
Secondary outcomes:
measure: Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)
timeFrame: During Procedure
measure: Procedure duration
timeFrame: During Procedure
measure: Robot duration
timeFrame: During Procedure
measure: Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
timeFrame: During Procedure
measure: Contrast Volume in mL
timeFrame: During Procedure
measure: Rate of Bleeding or Vascular Complications
timeFrame: Up to 1 month
measure: 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)
timeFrame: Post-Procedure, 1 month
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Het Ziekenhuisnetwerk Antwerpen vzw
city: Caen
country: France
facility: CHU Caen Normandie
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: Clinique Pasteur
city: Luxembourg
country: Luxembourg
facility: INCCI
city: Rotterdam
country: Netherlands
facility: Maastad Ziekenhuis
Study officials:
References: