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

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

      • Antwerpen, Belgium, 2000
        • Het Ziekenhuisnetwerk Antwerpen vzw
      • Caen, France, 14033
        • CHU Caen Normandie
      • Rouen, France, 76000
        • CHU Rouen
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Luxembourg, Luxembourg, L-1210
        • INCCI
      • Rotterdam, Netherlands, 3079
        • Maastad Ziekenhuis

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
PCI with robotic assistance
PCI with robotic assistance

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
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
Peri-procedure
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
During Procedure

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
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
During Procedure
Procedure duration
Time Frame: During Procedure
Time between arterial sheath introduction and sheath removal
During Procedure
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
During Procedure
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
Time Frame: During Procedure
Patient and Operator
During Procedure
Contrast Volume in mL
Time Frame: During Procedure
Measure of the volume of injected contrast media
During Procedure
Rate of Bleeding or Vascular Complications
Time Frame: Up to 1 month
BARC definition
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
ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization
Post-Procedure, 1 month

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

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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