Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000480684
Ethics application status
Approved
Date submitted
20/02/2023
Date registered
12/05/2023
Date last updated
7/07/2023
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Percutaneous Coronary Intervention in patients with coronary artery disease using assisted robotic technology: a randomised controlled trial
Scientific title
The impact of a Percutaneous Coronary Intervention using assisted robotic technology on radiation exposure in patients with coronary artery disease: a randomised controlled trial
Secondary ID [1] 309042 0
None
Universal Trial Number (UTN)
Trial acronym
The PARTY (Percutaneous coronary intervention using Assisted Robotic TechnologY) trial
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 329094 0
Condition category
Condition code
Cardiovascular 326069 326069 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two treatment arms are 1. patients undergoing PCI with robotic assistance and 2. patients undergoing PCI via manual (traditional approach). All patients undergoing PCI will be asked to participate in this clinical trial which compares robotic PCI versus manual standard PCI. These procedures will be performed face to face in our hospital by interventional cardiologists specifically trained to operate the robot with a minimum of 5 supervised cases performed already. The PCI procedure requires the injection of iodine based contrast and use of X rays to visualise the coronary arteries and the areas of stenosis (narrowing). The duration of these procedures can vary from 1-4 hours depending on the number of lesions and their complexity. The amount of dye to be injected varies depending on how many angiogram pictures are required. Patients participating will either be hospital inpatients or outpatients attending for day only procedures. Most patients will have only one procedure however patient will multiple lesions requiring PCI may return for multiple PCI procedures. Whether or not all the lesions are treated with the robot (or by a hybrid of manual and robotic PCI) will be at the discretion of the treating cardiologist. Patients will be followed up for clinical outcomes until hospital discharge or 72hrs (whichever occurs first), at day 30 and day 365. The day 30 and day 365 reviews will be completed over the phone.
Intervention code [1] 325477 0
Treatment: Devices
Comparator / control treatment
The current standard of care is PCI is performed manually by the Cardiologist. This involves positioning catheters at the origin of the coronary artery and then passing wires and balloons down the artery to the coronary artery stenosis (narrowing) under X ray guidance. The stenosis is dilated with a balloon and then a stent is deployed at that location to maintain the artery patency. The time required for this procedure is very variable and can range from 60 minutes for simple procedures up to 3-4 hours for complex and multiple lesions.
Control group
Active

Outcomes
Primary outcome [1] 333929 0
We will compare patient radiation exposure (as measured via individual dosimeters) between those undergoing PCI via robotic approach to those undergoing PCI via manual approach
Timepoint [1] 333929 0
Immediately post procedure
Secondary outcome [1] 418773 0
Clinical success which is defined as less than 30% residual stenosis (visual estimate) post PCI, without in-hospital major adverse coronary events (MACE). Possible adverse events of note including death, myocardial infarction, stent thrombosis, target lesion revascularisation, arrhythmia, serious bleeding, contrast induced nephropathy or vascular injury. These adverse events will be screened by the clinical team at the end of the PCI procedure, at discharge (or day 3 whichever occurs first) and phone calls at Day 30 and Day 365 or review of medical records. The events will then be reviewed by a blinded and independent adjudication committee.
Timepoint [1] 418773 0
End of PCI procedure, day 3, day 30 and day 365

Eligibility
Key inclusion criteria
• Age between 18 years to 85 years
• Patients with coronary artery disease with clinical indication for PCI
• Patient deemed appropriate for robotic-assisted PCI
• Provided a signed and dated informed consent form
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software by the study Statistician
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a double-arm, open-label, randomized controlled trial of the CorPath GRX System de-signed to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath GRX System in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and remote manipulation of guide catheters for use in PCI in comparison to standard of care. The analysis of data collected as part of the RCT will include, but may not be limited to the Objectives and Measures outlined in Section 3.0 of this protocol. Standard statistical meth-ods will be utilized. Continuous variables will be summarized using the number of observations, mean, standard deviation, median, min and max values. Categorical variables will be summarized with the number and percent in each category out of the number observed. Two-sided 95% confidence intervals may be calculated and two-sided p-values < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
29/06/2023
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
600
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24080 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 39589 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 313246 0
Charities/Societies/Foundations
Name [1] 313246 0
Ingham Institute for Applied Medical Research
Country [1] 313246 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Locked Bag 7279
LIVERPOOL BC 1871
Country
Australia
Secondary sponsor category [1] 314975 0
None
Name [1] 314975 0
Address [1] 314975 0
Country [1] 314975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312477 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312477 0
Locked Bag 7279
LIVERPOOL BC 1871
Ethics committee country [1] 312477 0
Australia
Date submitted for ethics approval [1] 312477 0
31/10/2022
Approval date [1] 312477 0
21/12/2022
Ethics approval number [1] 312477 0
2022/ETH02267

Summary
Brief summary
Coronary artery disease is a leading cause of death globally, nationally and locally. Currently in South Western Sydney Local Health District Interventional Cardiologists perform Percutaneous Coronary intervention (PCI) procedure which opens coronary arteries that are narrowed or blocked by the build-up of atherosclerotic plaque. PCI may also be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack. With new technology, engineering and training development, a technology-assisted percutaneous coronary intervention (PCI) device has the potential to increase procedural accuracy, reduce radiation exposure to patients and staff, improved ergonomics, and reduce major adverse cardiac events. To date we are not aware of any randomised controlled trial data supporting this technology
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124802 0
Prof Craig Juergens
Address 124802 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Country 124802 0
Australia
Phone 124802 0
+61 2 87323073
Fax 124802 0
Email 124802 0
Craig.Juergens@health.nsw.gov.au
Contact person for public queries
Name 124803 0
Dr James Leung
Address 124803 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Country 124803 0
Australia
Phone 124803 0
+61 287323073
Fax 124803 0
Email 124803 0
james.leung@health.nsw.gov.au
Contact person for scientific queries
Name 124804 0
Dr James Leung
Address 124804 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Country 124804 0
Australia
Phone 124804 0
+61 287323073
Fax 124804 0
Email 124804 0
james.leung@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregated data will be made available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.