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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Percutaneous Coronary Intervention Procedure: Percutaneous Coronary Intervention Device: Percutaneous Coronary Intervention using R-One assistance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: R-One Efficiency For PCI Evolution With Robotic Assistance
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : March 17, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: R-One
Patients treated with robotic assistance
Procedure: Percutaneous Coronary Intervention
PCI with robotic assistance

Device: Percutaneous Coronary Intervention using R-One assistance
PCI with robotic assistance




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Procedure duration [ Time Frame: During Procedure ]
    Time between arterial sheath introduction and sheath removal

  3. 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

  4. Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose) [ Time Frame: During Procedure ]
    Patient and Operator

  5. Contrast Volume in mL [ Time Frame: During Procedure ]
    Measure of the volume of injected contrast media

  6. Rate of Bleeding or Vascular Complications [ Time Frame: Up to 1 month ]
    BARC definition

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163393


Contacts
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Contact: Jean Fajadet, Dr +33 5 62 21 31 86 jfajadet@clinique-pasteur.com
Contact: Eric Durand, Dr +33 2 32 88 82 43 eric.durand@chu-rouen.fr

Locations
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Belgium
Het Ziekenhuisnetwerk Antwerpen vzw Not yet recruiting
Antwerpen, Belgium, 2000
Contact: Stefan Verheye, Prof. Dr.       stefan.verheye@gmail.com   
France
CHU Caen Normandie Not yet recruiting
Caen, France, 14033
Contact: Rémi Sabatier, Dr       sabatier-r@chu-caen.fr   
CHU Rouen Recruiting
Rouen, France, 76000
Contact: Eric Durand, Dr    +33 2 32 88 82 43    eric.durand@chu-rouen.fr   
Clinique Pasteur Active, not recruiting
Toulouse, France, 31076
Luxembourg
INCCI Not yet recruiting
Luxembourg, Luxembourg, L-1210
Contact: Bruno Pereira, Dr       pereira.bruno@incci.lu   
Netherlands
Maastad Ziekenhuis Not yet recruiting
Rotterdam, Netherlands, 3079
Contact: Peter Smits, Dr       smitsp@maastadziekenhuis.nl   
Sponsors and Collaborators
Robocath
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Responsible Party: Robocath
ClinicalTrials.gov Identifier: NCT04163393    
Other Study ID Numbers: ROB-01
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robocath:
Coronary Artery Disease
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases