NCT04163393 (R-EVOLUTION) is a NA clinical trial of Percutaneous Coronary Intervention in Coronary Artery Disease, sponsored by Robocath.

Who is sponsoring NCT04163393?

NCT04163393 is sponsored by Robocath.

What drugs are being tested in NCT04163393?

Interventions in NCT04163393: Percutaneous Coronary Intervention, Percutaneous Coronary Intervention using R-One assistance.

What condition does NCT04163393 study?

NCT04163393 studies Coronary Artery Disease, Percutaneous Coronary Intervention.

Is NCT04163393 still recruiting?

NCT04163393 is currently completed. Last updated 8 February 2022.

Last reviewed 2022-02-08 · How we verify

NCT04163393: R-EVOLUTION

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

R-One Efficiency For PCI Evolution With Robotic Assistance

Completed NA Last updated 8 February 2022

What this trial tests

NA trial testing Percutaneous Coronary Intervention in Coronary Artery Disease in 62 participants. Completed in 15 December 2021.

Timeline

17 September 2019

Primary endpoint
8 November 2021

15 December 2021

Quick facts

Lead sponsor	Robocath
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	17 September 2019
Primary completion	8 November 2021
Estimated completion	15 December 2021
Sites	6 locations across Belgium, France, Netherlands, Luxembourg

Drugs / interventions tested

Percutaneous Coronary Intervention
Percutaneous Coronary Intervention using R-One assistance

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →
Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →

Sponsor

Robocath

Who can join

18 and older, any sex, with Coronary Artery Disease or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.
Durand E, Sabatier R, Smits PC, Verheye S, et al · · 2023 · cited 27× · PMID 36602883 · DOI 10.4244/eij-d-22-00642

Verify or expand the search:

Other trials of Percutaneous Coronary Intervention

Trials testing the same drug.

NCT07373678 — CABG Versus PCI in Patients With Isolated LAD Chronic Total Occlusion · completed
NCT07303439 — Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation · NA · recruiting
NCT07034157 — A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Cor · recruiting
NCT06654453 — The Thrombus Aspiration During PCI After Thrombolysis in STEMI · NA · recruiting
NCT06779110 — Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Res · NA · recruiting

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting

Other Robocath trials

Trials by the same sponsor.

NCT05093127 — CArotid Robotic Procedure Evaluation · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04163393 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Robocath
Last refreshed: 8 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04163393.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing