The ROB-OSTIAL Study

Robotically Assisted PCI in Ostial Lesions

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Robotic-assisted PCI with Corpath GRX® System; Procedure: Standard PCI

Detailed Description

To assess accuracy of robotic-assisted PCI in obtaining full ostial lesion coverage and minimal protrusion compared to standard PCI.

Robotically assisted PCI offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. This feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. Robotic-assisted PCI for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard PCI.

The aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted PCI (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded).

Primary endpoint of the study will be full ostial coverage as assessed by IVUS imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by IVUS imaging.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RA
    • Cotignola, RA, Italy, 48033
      • Maria Cecilia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robotic-assisted PCI with Corpath GRX® System; Percutaneous coronary intervention (PCI) using the Corpath GRX System.	Device: Robotic-assisted PCI with Corpath GRX® System; 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).
Active Comparator: Standard PCI; Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance.	Procedure: Standard PCI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance From Most Proximal Stent Strut and Coronary Ostium (mm), as Assessed by IVUS	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	Defined as the duration from when the sheath is inserted until it is removed	Measured at end of procedure
Major Adverse Cardiovascular Events at 1 Month Follow-up		Measured at 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of participants with in-hospital major cardiovascular events		Measured at discharge or 72 hours, whichever comes first
Procedural duration	Defined as the duration from when the sheath is inserted until it is removed	Measured at end of procedure
Major adverse cardiovascular events at 1 month follow-up		Measured at 1 month

Collaborators and Investigators

• Sponsor: Corindus Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: PCI; Ostial Lesion; Robotic-assisted PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 104-13191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes