Coronary Artery DiseaseR-EVOLUTIONNCT04163393
R-One Efficiency For PCI Evolution With Robotic Assistance
A study testing Percutaneous Coronary Intervention and Percutaneous Coronary Intervention using R-One assistance in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Robocath at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous Coronary Intervention and Percutaneous Coronary Intervention using R-One assistance
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 17 Sep 2019to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France3 sites
CHU Caen Normandie
Caen, 14033
CHU Rouen
Rouen, 76000
Clinique Pasteur
Toulouse, 31076
About this study
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.
- Being tested
- Percutaneous Coronary Intervention, Percutaneous Coronary Intervention using R-One assistance
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
PCI with robotic assistance
Percutaneous Coronary Intervention using R-One assistanceDevice
PCI with robotic assistance
| Study group | Role | What they receive |
|---|---|---|
| R-One | Experimental | Patients treated with robotic assistance Receives: Procedure: Percutaneous Coronary Intervention; Device: Percutaneous Coronary Intervention using R-One assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Peri-procedure
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
Measured: During Procedure
Secondary outcomes (7)
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
Measured: During Procedure
Procedure duration
Time between arterial sheath introduction and sheath removal
Measured: During Procedure
Robot duration
From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
Measured: During Procedure
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
Patient and Operator
Measured: During Procedure
Contrast Volume in mL
Measure of the volume of injected contrast media
Measured: During Procedure
Rate of Bleeding or Vascular Complications
BARC definition
Measured: Up to 1 month
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
Measured: Post-Procedure, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start17 Sep 2019
- Primary completion8 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robocath
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163393
- Sponsor's protocol ID
- ROB-01
- Acronym
- R-EVOLUTION
- Status last verified
- Feb 2022
- First submitted
- 15 Oct 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durand E, Sabatier R, Smits PC, Verheye S, Pereira B, Fajadet J. Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study. EuroIntervention. 2023 Apr 3;18(16):e1339-e1347. doi: 10.4244/EIJ-D-22-00642.
PubMed 36602883
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R-One Efficiency For PCI Evolution With Robotic Assistance
- ClinicalTrials.gov ID
- NCT04163393
- Acronym / sponsor ID
- R-EVOLUTION / ROB-01
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- RobocathIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-One | Experimental | Procedure: Percutaneous Coronary Intervention, Device: Percutaneous Coronary Intervention using R-One assistancePatients treated with robotic assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (14 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionPCI with robotic assistance | Procedure or surgery | R-One |
| Percutaneous Coronary Intervention using R-One assistancePCI with robotic assistance | Device | R-One |
Primary outcome
Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)
Time frame: Peri-procedure
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
Time frame: During Procedure
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
7 secondary outcomes
Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)
Time frame: During Procedure
Procedure duration
Time frame: During Procedure
Robot duration
Time frame: During Procedure
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
Time frame: During Procedure
Contrast Volume in mL
Time frame: During Procedure
Rate of Bleeding or Vascular Complications
Time frame: Up to 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 36602883Durand E, Sabatier R, Smits PC, Verheye S, Pereira B, Fajadet J. Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study. EuroIntervention. 2023 Apr 3;18(16):e1339-e1347. doi: 10.4244/EIJ-D-22-00642.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention and Percutaneous Coronary Intervention using R-One assistance in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Robocath at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Belgium, Luxembourg, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta) (time frame: Peri-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04163393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.