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Finished

R-One Efficiency For PCI Evolution With Robotic Assistance

NCT04163393 · Robocath · Updated 8 Feb 2022

What is being tested
Percutaneous Coronary Intervention; Percutaneous Coronary Intervention using R-One assistance
For
Coronary Artery Disease; Percutaneous Coronary Intervention
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 62 people. The full rules are on the registry page.
Where
Belgium, France, Luxembourg, Netherlands (6 sites)
When
Starts or started 17 Sept 2019, ends 15 Dec 2021. Registered 14 Nov 2019.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT04163393

Sites

  • Het Ziekenhuisnetwerk Antwerpen vzwAntwerp, Belgium
  • CHU Caen NormandieCaen, France
  • CHU RouenRouen, France
  • Clinique PasteurToulouse, France
  • INCCILuxembourg, Luxembourg
  • Maastad ZiekenhuisRotterdam, Netherlands