- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163393
R-One Efficiency For PCI Evolution With Robotic Assistance (R-EVOLUTION)
February 7, 2022 updated by: Robocath
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium, 2000
- Het Ziekenhuisnetwerk Antwerpen vzw
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Caen, France, 14033
- CHU Caen Normandie
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Rouen, France, 76000
- CHU Rouen
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Toulouse, France, 31076
- Clinique Pasteur
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Luxembourg, Luxembourg, L-1210
- INCCI
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Rotterdam, Netherlands, 3079
- Maastad Ziekenhuis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R-One
Patients treated with robotic assistance
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PCI with robotic assistance
PCI with robotic assistance
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)
Time Frame: Peri-procedure
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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
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Peri-procedure
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Efficacy Endpoint: Number of Patients with Procedure technical success
Time Frame: During Procedure
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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
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During Procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)
Time Frame: During Procedure
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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
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During Procedure
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Procedure duration
Time Frame: During Procedure
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Time between arterial sheath introduction and sheath removal
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During Procedure
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Robot duration
Time Frame: During Procedure
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From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
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During Procedure
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Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
Time Frame: During Procedure
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Patient and Operator
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During Procedure
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Contrast Volume in mL
Time Frame: During Procedure
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Measure of the volume of injected contrast media
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During Procedure
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Rate of Bleeding or Vascular Complications
Time Frame: Up to 1 month
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BARC definition
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Up to 1 month
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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)
Time Frame: Post-Procedure, 1 month
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ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization
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Post-Procedure, 1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2019
Primary Completion (Actual)
November 8, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
November 13, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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