The ROB-OSTIAL Study

Coronary Artery Disease Clinical Trial

Official title:

Robotically Assisted PCI in Ostial Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05634538
• Other study ID #: 104-13191
• Status: Terminated
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: May 8, 2023

Study information

• Verified date: September 2023
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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).

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.

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	RA

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of participants with in-hospital major cardiovascular events		Measured at discharge or 72 hours, whichever comes first
Other	Procedural duration	Defined as the duration from when the sheath is inserted until it is removed	Measured at end of procedure
Other	Major adverse cardiovascular events at 1 month follow-up		Measured at 1 month
Primary	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	Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS		Measured at end of procedure