NCT05853419

Brief Summary

The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
6 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

February 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

February 28, 2023

Last Update Submit

August 14, 2025

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (2)

  • Clinical success

    Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse cardiac events (MACE).

    From Day 0 to Day 3

  • Technical success

    Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion

    During procedure

Secondary Outcomes (6)

  • Radiation exposure for the patient

    During procedure

  • Overall Procedure Time

    During procedure

  • Overall contrast volume

    During procedure

  • Radiation exposure for the operator

    During procedure

  • Fluoroscopy Time

    During procedure

  • +1 more secondary outcomes

Study Arms (1)

Study population

Adult patients with coronary artery disease and a clinical indication for PCI

Device: Robotic-assisted PCI

Interventions

Robotic-assisted PCIDEVICE

Robotic-assisted PCI will be performed according to the routine hospital practices, current scientific guidelines and following Instructions for Use (IFU) provided by the manufacturer

Study population

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with coronary artery disease and a clinical indication for PCI

You may qualify if:

  • \. Age ≥ 18 years;
  • Subjects with coronary artery disease with clinical indication for PCI;
  • Subject deemed appropriate for robotic-assisted PCI; and
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

  • Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or
  • The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI.
  • STEMI
  • Cardiogenic shock
  • Subjects will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Het Ziekenhuisnetwerk Antwerpen vzw

Antwerp, 2000, Belgium

RECRUITING

Brest university hospital

Brest, Brittany Region, 29609, France

RECRUITING

Rouen university hospital

Rouen, 76000, France

RECRUITING

Centre Cardiologique du Nord

Saint-Denis, Île-de-France Region, 93200, France

RECRUITING

Rheinland Klinikum Neuss GmbH

Neuss, Lukaskrankenhaus, 41464, Germany

RECRUITING

San Donato Policlinco Kardia

San Donato Milanese, MI, 20097, Italy

NOT YET RECRUITING

Polskie Towarzystwo Kardiologiczne

Warsaw, Par Défaut, 02-507, Poland

NOT YET RECRUITING

Netcare Christiaan Barnard Memorial Hospital

Cape Town, le Cap, 8001, South Africa

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stefan Verheye, Prof.MD

    Het Ziekenhuisnetwerk Antwerpen vzw

    PRINCIPAL INVESTIGATOR

  • Michael Haude, Prof.MD

    Rheinland Klinikum Neuss GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamouda Abassi, PhD

CONTACT

+33 2 32 10 67 42hamouda.abassi@robocath.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

May 10, 2023

Study Start

June 20, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)DE(1)BE(1)PL(1)ZA(1)FR(3)