Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    R evolution
Previous Study | Return to List | Next Study

R-One Efficiency For PCI Evolution With Robotic Assistance (R-EVOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163393
Recruitment Status : Unknown
Verified October 2019 by Robocath.
Recruitment status was:  Recruiting
First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Robocath

Tracking Information
First Submitted Date  ICMJE October 15, 2019
First Posted Date  ICMJE November 14, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE September 17, 2019
Estimated Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta) [ Time Frame: During Procedure ]
    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
  • Procedure duration [ Time Frame: During Procedure ]
    Time between arterial sheath introduction and sheath removal
  • Robot duration [ Time Frame: During Procedure ]
    From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
  • Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose) [ Time Frame: During Procedure ]
    Patient and Operator
  • Contrast Volume in mL [ Time Frame: During Procedure ]
    Measure of the volume of injected contrast media
  • Rate of Bleeding or Vascular Complications [ Time Frame: Up to 1 month ]
    BARC definition
  • 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 ]
    ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE R-One Efficiency For PCI Evolution With Robotic Assistance
Official Title  ICMJE R-One Efficiency For PCI Evolution With Robotic Assistance
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
Intervention  ICMJE
  • Procedure: Percutaneous Coronary Intervention
    PCI with robotic assistance
  • Device: Percutaneous Coronary Intervention using R-One assistance
    PCI with robotic assistance
Study Arms  ICMJE Experimental: R-One
Patients treated with robotic assistance
Interventions:
  • Procedure: Percutaneous Coronary Intervention
  • Device: Percutaneous Coronary Intervention using R-One assistance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Luxembourg,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04163393
Other Study ID Numbers  ICMJE ROB-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robocath
Study Sponsor  ICMJE Robocath
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Robocath
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP