Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001310257
Ethics application status
Approved
Date submitted
26/07/2018
Date registered
6/08/2018
Date last updated
19/03/2020
Date data sharing statement initially provided
19/03/2020
Type of registration
N/A

Titles & IDs
Public title
The outcome of a new vascular stent in patients with arterial disease in the legs
Scientific title
Observational Registry Study of Peripheral Arterial Disease Patients Treated with GORE TIGRIS Vascular Stent
Secondary ID [1] 295520 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Tigris Registry of Australian Experiences (TRUE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Diseaes 308783 0
Femoro-popliteal Arterial Disease 308784 0
Chronic Limb Ischaemia 308786 0
Claudication 308787 0
Critical Limb Ischaemia 308788 0
Condition category
Condition code
Cardiovascular 307724 307724 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
The GORE TIGRIS stent has had promising results in terms of previous literature.
Patients who receive the GORE TIGRIS stent as part of their routine clinical care at the discretion of their treating vascular surgeons will be identified post operatively by study personnel. At this stage, they will be approached by one of the researchers, at a suitable time point during their routine hospital attendance, and at such time will be invited to participate in the trial. Patient information sheets and consent forms will be provided to potential prospective patients for review, and following all responses to questions and if they wish to participate, written informed consent will be obtained and the patient will be enrolled into the study.

Patients who have received treatment of their femoro-popliteal arterial disease with this stent attend routine outpatient clinic visits at 3, 6, 12, 24 and 36 months. At each follow-up clinic patients will undergo routine assessment, which will include clinical assessment of symptomatology and duplex ultrasound for evidence of stent patency, occlusion or fracture. Any surgical re-interventions undertaken to the area treated with the GORE TIGRIS stent will be recorded. This information will be collected on all enrolled patients to a minimum of 12 months, with an aim to continue data collection on all patients out to 3 years.
Intervention code [1] 301984 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306886 0
Primary patency via duplex ultrasound
Timepoint [1] 306886 0
3, 6, 9, 12, 24 and 36 months
Secondary outcome [1] 350030 0
Primary assisted patency via US duplex
Timepoint [1] 350030 0
3, 6, 9, 12, 24 and 36 months
Secondary outcome [2] 350157 0
Secondary patency via duplex ultrasound
Timepoint [2] 350157 0
3, 6, 9, 12, 24 and 36 months
Secondary outcome [3] 350158 0
Rate of stent fracture via X-ray
Timepoint [3] 350158 0
3, 6, 9, 12. 18 and 24 months

Eligibility
Key inclusion criteria
Aged 18 years or above
Patients with arterial disease from the SFA origin to the popliteal bifurcation scheduled to be treated or have been treated with the TIGRIS GORE stent
De novo lesions and post-angioplasty stenoses
All lesion lengths suitable for a TIGRIS GORE stent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lesions with in-stent restenosis
Patients contraindicated to having dual antiplatelet or anticoagulation therapy including a history of heparin induced thrombocytopenia and thrombosis (HITTS)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study withdrawn because stent is no longer manufactured
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300251 0
Self funded/Unfunded
Name [1] 300251 0
Investigator led study
Country [1] 300251 0
Australia
Primary sponsor type
Individual
Name
Dr. Vikram Puttaswamy (Investigator)
Address
Department of vascular surgery
Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 299670 0
Commercial sector/Industry
Name [1] 299670 0
W L Gore & associates Asutralia
Address [1] 299670 0
13A Narabang Way Belrose NSW 2085
Country [1] 299670 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300945 0
Northern Sydney Local Health District HREC Executive Committee
Ethics committee address [1] 300945 0
Research Office
Kolling Building, Level 13
Royal North Shore Hospital
Reserve Rd
St Leonards NSW 2065
Ethics committee country [1] 300945 0
Australia
Date submitted for ethics approval [1] 300945 0
01/05/2018
Approval date [1] 300945 0
24/05/2018
Ethics approval number [1] 300945 0
RESP/17/122

Summary
Brief summary
The newer generation TIGRIS GORE nitinol stent observed in this study has been used successfully in many practices in Australia. Given the clinical equipoise surrounding the optimal choice of stent in the treatment of femoropopliteal artery disease, it is routine practice for some surgeons and centres to choose to use this stent for their patients. This study will act as a registry for patients who receive a GORE TIGRIS stent in treatment of their peripheral artery disease, and serve to provide further data for use of this stent in a real-world setting.
Trial website
Trial related presentations / publications
Study withdrawn - no publications written
Public notes
Study is withdrawn becuase the stent is no longer manufactured

Contacts
Principal investigator
Name 85370 0
Dr Vikram Puttaswamy
Address 85370 0
Department of Vascular Surgery
Royal North Shore Hospital
Reserve Rd
Sydney NSW 2065
Country 85370 0
Australia
Phone 85370 0
+61 2 94631767
Fax 85370 0
Email 85370 0
[email protected]
Contact person for public queries
Name 85371 0
Miss Linda Pallot
Address 85371 0
Department of Vascular Surgery
Royal North Shore Hospital
Reserve Rd
Sydney NSW 2065
Country 85371 0
Australia
Phone 85371 0
+61 2 94631767
Fax 85371 0
Email 85371 0
[email protected]
Contact person for scientific queries
Name 85372 0
Dr Vikram Puttaswamy
Address 85372 0
Department of Vascular Surgery
Royal North Shore Hospital
Reserve Road
St. Leonards
Sydney NSW 2065
Country 85372 0
Australia
Phone 85372 0
+61 2 94631767
Fax 85372 0
Email 85372 0
[email protected]

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


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.