Study Results
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View full resultsBasic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2023-03-30
2023-05-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic-assisted PCI with Corpath GRX® System
Percutaneous coronary intervention (PCI) using the Corpath GRX System.
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).
Standard PCI
Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Corindus Inc.
INDUSTRY
Responsible Party
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Locations
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Maria Cecilia Hospital
Cotignola, RA, Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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104-13191
Identifier Type: -
Identifier Source: org_study_id
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