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Trial registered on ANZCTR


Registration number
ACTRN12619000516189p
Ethics application status
Not yet submitted
Date submitted
26/02/2019
Date registered
1/04/2019
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A retrospective cohort study to evaluate outcomes in carotid endartertomy vs carotid artery stenting in carotid artery disease
Scientific title
A retrospective cohort study to evaluate outcomes in carotid endartertomy vs carotid artery stenting in carotid artery disease
Secondary ID [1] 297531 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carotid disease 311742 0
Condition category
Condition code
Surgery 310368 310368 0 0
Other surgery
Stroke 310556 310556 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Carotid Endarterectomy
Patients observed in this study are those with unilateral and or bilateral carotid artery stenosis and/or occlusion. They underwent either Carotid endarterectomy or Carotid artery stenting, performed by one primary surgeon. The decision to offer carotid endarterectomy vs carotid artery stenting was based on the surgeons clinical assessment of the patient.

All patients recruited will have had their procedures performed at Hollywood Private Hospital, Nedlands, WA or Royal Perth Hospital, Perth, WA between the years 2006 and 2018.
All patients have been followed at 3 and 6 months with imaging and in person at 1 year post op by the same primary surgeon in his rooms.
Intervention code [1] 313765 0
Diagnosis / Prognosis
Comparator / control treatment
Carotid artery stenting for patients with carotid artery stenosis/occlusion
Control group
Active

Outcomes
Primary outcome [1] 319242 0
New ischaemic lesions as diagnosed on post-operative DW-MRI.
Timepoint [1] 319242 0
2-14 days post operatively
Secondary outcome [1] 367405 0
Development of stenosis or progression of pre-existing stenosis in the external carotid artery,
Timepoint [1] 367405 0
ultrasound of neck bilaterally at at 6 months and 1 year post operatively
Secondary outcome [2] 367534 0
Stroke
Timepoint [2] 367534 0
immediately post operatively by neurological examination and DWI-MRI
in the one year follow up period post op by neurological examination
Secondary outcome [3] 367535 0
Transient Ischaemia Attack
Timepoint [3] 367535 0
immediately post operatively by neurological examination, review of medical records
in the one year follow up period post op by patient history
Secondary outcome [4] 367536 0
Myocardial Infarction
Timepoint [4] 367536 0
peri operatively
immediately post operatively
in the one year follow up period post op
by review of medical records

Eligibility
Key inclusion criteria
All patients who underwent either Carotid artery stenting or Carotid endarterectomy performed by one vascular surgeon between the years 2006 and 2018 are included
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included allergy to heparin, aspirin or clopidogrel, contraindication to MRI, intracranial hemorrhage, dementia or neurologic illness that might confound neurological evaluation.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The primary end point is the evidence of new ischaemic lesions on postoperative DW-MRI. Continuous variables will be expressed as the mean and standard deviation. Categoric data will be compared using the fisher exact test and summarized as absolute frequencies and percentages. An unpaired student t-test will be used to compare continuous variables between the two cohorts and statistical significance is defined as p<0.5.
Binary regression models to compare DW-MRI measures between the two groups will be used. Interactions between the effect of intervention type on the primary outcome measure and selected variables (age, symptomatic status, stent type) will be investigated and adjusted for any significant imbalances in baseline characteristic.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13258 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 25818 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 302089 0
Self funded/Unfunded
Name [1] 302089 0
In Kind - time put in by primary surgeon/chief investigato and associate investigator
Country [1] 302089 0
Australia
Primary sponsor type
Individual
Name
Dr Kishore Siuenarine
Address
Hollywood Private Hospital
Monash Avenue
Nedlands, 6009, Western Australia
Country
Australia
Secondary sponsor category [1] 301910 0
Individual
Name [1] 301910 0
Dr Rebekah Tan
Address [1] 301910 0
Hollywood Private Hospital
Monash Avenue
Nedlands, 6009, Western Australia
Country [1] 301910 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302768 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 302768 0
Hollywood Private Hospital
Monash Avenue
Nedlands, 6009, Western Australia
Ethics committee country [1] 302768 0
Australia
Date submitted for ethics approval [1] 302768 0
04/04/2019
Approval date [1] 302768 0
Ethics approval number [1] 302768 0

Summary
Brief summary
Stroke is the most common life threatening and debilitating neurological disorder. It is commonly caused by the flicking off of plaque from calcified arteries in the neck region in patients with atherosclerotic internal carotid artery stenosis.
This study retrospectively compares the outcomes after 2 different treatment options for carotid artery stenosis: carotid artery stenting (CAS) and carotid endarterecromy (CEA). All patients who underwent either procedure performed by the primary surgeon, in 4 locations will be included. Specific outcome measures are: (1) post procedure occurrence of further clots in the arteries supplying the brain and (2) post procedure occurrence of external carotid (a branch of the artery being operated on) occlusion.
In order to measure these outcomes, we will compare the clinical examination findings as well as imaging (MRI, ultrasound, CT angiography) results pre and post operatively.
As CEA is currently the gold standard for treating this condition, we predict that long term outcomes are better in CEA as compared to CAS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91334 0
Dr Kishore Sieunarine
Address 91334 0
Hollywood Private Hospital
Monash Avenue
Nedlands 6009, WA
Country 91334 0
Australia
Phone 91334 0
+61 893466000
Fax 91334 0
Email 91334 0
kishore@westcoastvascular.com.au
Contact person for public queries
Name 91335 0
Dr Kishore Sieunarine
Address 91335 0
Hollywood Private Hospital
Monash Avenue
Nedlands 6009, WA
Country 91335 0
Australia
Phone 91335 0
+61 893466000
Fax 91335 0
Email 91335 0
kishore@westcoastvascular.com.au
Contact person for scientific queries
Name 91336 0
Dr Kishore Sieunarine
Address 91336 0
Hollywood Private Hospital
Monash Avenue
Nedlands 6009, WA
Country 91336 0
Australia
Phone 91336 0
+61 893466000
Fax 91336 0
Email 91336 0
kishore@westcoastvascular.com.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1457Study protocol    377069-(Uploaded-26-02-2019-12-56-27)-Study-related document.docx



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.