NCT05634538

Brief Summary

The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions. CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart. The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 17, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

November 17, 2022

Results QC Date

April 23, 2025

Last Update Submit

May 15, 2025

Conditions

Coronary Artery Disease

Keywords

Ostial LesionRobotic-assisted PCIPCI

Outcome Measures

Primary Outcomes (1)

  • Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment

    Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)

    Measured at end of procedure

Secondary Outcomes (4)

  • Distance From Most Proximal Stent Strut and Coronary Ostium (mm), as Assessed by IVUS

    Measured at end of procedure

  • Comparison of Participants With In-hospital Major Cardiovascular Events

    Measured at discharge or 72 hours, whichever comes first

  • Procedural Duration

    Measured at end of procedure

  • Major Adverse Cardiovascular Events at 1 Month Follow-up

    Measured at 1 month

Study Arms (2)

Robotic-assisted PCI with Corpath GRX® System

ACTIVE COMPARATOR

Percutaneous coronary intervention (PCI) using the Corpath GRX System.

Device: Robotic-assisted PCI with Corpath GRX® System

Standard PCI

ACTIVE COMPARATOR

Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance.

Procedure: Standard PCI

Interventions

Robotic-assisted PCI with Corpath GRX® SystemDEVICE

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary interventions (PCI).

Robotic-assisted PCI with Corpath GRX® System
Standard PCIPROCEDURE

Percutaneous coronary intervention (PCI) is a procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart. This arm will be completed without robotic assistance.

Standard PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or nonpregnant female aged ≥18 years
  • Coronary OSTIAL lesion suitable for percutaneous coronary intervention (PCI)
  • 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:

  • Cardiogenic shock or hemodynamic instability requiring support.
  • ST-elevation myocardial infarction.
  • Ongoing acute renal failure.
  • In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status and/or anatomic characteristics
  • More than one lesion to be treated
  • Ostial left main disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Cecilia Hospital

Cotignola, RA, 48033, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Alison Lord
Organization
Corindus
alison.lord@siemens-healthineers.com
617-943-5472

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 2, 2022

Study Start

March 30, 2023

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

June 4, 2025

Results First Posted

June 4, 2025

Record last verified: 2025-05

Locations

IT(1)