Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02568293




Registration number
NCT02568293
Ethics application status
Date submitted
1/10/2015
Date registered
5/10/2015
Date last updated
9/02/2017

Titles & IDs
Public title
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
Scientific title
A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery
Secondary ID [1] 0 0
TP-1601
Universal Trial Number (UTN)
Trial acronym
SHIELD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SBCV
Other interventions - Saline

Experimental: SBCV - SBCV is administered to the site immediately post balloon dilation.

Placebo comparator: Control - Saline is used as a control and is delivered immediately post balloon dilation.


Other interventions: SBCV
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.

Other interventions: Saline
Saline is used as a control.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
through 24 weeks
Primary outcome [2] 0 0
Late Lumen Loss
Timepoint [2] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s)
* Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)
* Lesions are =70% stenosis by visual estimate
* A patent inflow artery free from significant lesion
* At least one patent native outflow artery to the ankle
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of haemorrhagic stroke within 3 months of screening
* History of myocardial infarction, thrombolysis or angina within 2 weeks of screening
* Renal failure or chronic kidney disease
* Severe calcification that renders the lesion undilatable

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2017
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Melbourne
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5043 - Adelaide
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3181 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Symic Vascular
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Symic Biomedical, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02568293