The ROB-OSTIAL Study

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Robotic-assisted PCI with Corpath GRX® System; Procedure: Standard PCI

• Registration Number: NCT05634538
• Lead Sponsor: Corindus Inc.

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.

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 Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-02
• Study Start: 2023-03-30
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic-assisted PCI with Corpath GRX® System	Robotic-assisted PCI with Corpath GRX® System	Percutaneous coronary intervention (PCI) using the Corpath GRX System.
Standard PCI	Standard PCI	Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance.

Primary Outcome Measures

Name	Time	Method
Evidence of full ostial coverage at angiographic and IVUS assessment	Measured at end of procedure	Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)

Secondary Outcome Measures

Name	Time	Method
Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS	Measured at end of procedure

Trial Locations

Locations (1)

Maria Cecilia Hospital; 🇮🇹 Cotignola, RA, Italy