Clinical trial NCT05634538: The ROB-OSTIAL Study
Official title: Robotically Assisted PCI in Ostial Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Ostial Lesion
Robotic-assisted PCI
PCI
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment
timeFrame: Measured at end of procedure
Secondary outcomes:
measure: Distance From Most Proximal Stent Strut and Coronary Ostium (mm), as Assessed by IVUS
timeFrame: Measured at end of procedure
measure: Comparison of Participants With In-hospital Major Cardiovascular Events
timeFrame: Measured at discharge or 72 hours, whichever comes first
measure: Procedural Duration
timeFrame: Measured at end of procedure
measure: Major Adverse Cardiovascular Events at 1 Month Follow-up
timeFrame: Measured at 1 month
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: RA
Study officials:
References: