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Trial details imported from ClinicalTrials.gov

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




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

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 - The composite of no all-cause perioperative (=30 day) mortality and none of the following events at 24 weeks following treatment:
Index limb amputation (above or below the ankle)
Index limb re-intervention
Index-limb-related death
Timepoint [1] 0 0
through 24 weeks
Primary outcome [2] 0 0
Late Lumen Loss - LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
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
Gender
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon
angioplasty alone for treatment of stenosis within the femoropopliteal artery.
Trial website
https://clinicaltrials.gov/show/NCT02568293
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02568293