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R-One Efficiency For PCI Evolution With Robotic Assistance

NCT04163393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-02-08

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Percutaneous Coronary Intervention

PCI with robotic assistance

DEVICE

Percutaneous Coronary Intervention using R-One assistance

PCI with robotic assistance

Sponsors & Collaborators

  • Robocath

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2021-11-08
Completion
2021-12-15

Countries

  • Belgium
  • France
  • Luxembourg
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163393 on ClinicalTrials.gov