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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01403077




Registration number
NCT01403077
Ethics application status
Date submitted
25/07/2011
Date registered
27/07/2011
Date last updated
6/09/2019

Titles & IDs
Public title
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
Scientific title
A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions
Secondary ID [1] 0 0
AVI-SFA2011-01
Universal Trial Number (UTN)
Trial acronym
STANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial Femoral Artery Lesions 0 0
Atherosclerosis of Femoral Artery 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
Treatment: Devices - 480 Biomedical Bioresorbable Scaffold System

Experimental: Scaffold Treatment -


Treatment: Devices: 480 Biomedical Bioresorbable Scaffold System
480 Biomedical Bioresorbable Scaffold System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major adverse events at 6 months post procedure
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Major adverse events at 1 month post procedure
Timepoint [1] 0 0
1 Month
Secondary outcome [2] 0 0
Major adverse events at 3, 12 months and 24 months post procedure
Timepoint [2] 0 0
3, 12 & 24 Months
Secondary outcome [3] 0 0
Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure
Timepoint [3] 0 0
1, 3, 6, 12, 24 Months
Secondary outcome [4] 0 0
Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure
Timepoint [4] 0 0
1, 3, 6, 12, 24 Months
Secondary outcome [5] 0 0
Walking Impairment Questionnaire
Timepoint [5] 0 0
1, 3, 6, 12, 24 Months
Secondary outcome [6] 0 0
Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure
Timepoint [6] 0 0
1, 3, 6, 12, 24 Months
Secondary outcome [7] 0 0
Clinically driven TLR at 3, 12 and 24 months post procedure
Timepoint [7] 0 0
3,12, 24 Months

Eligibility
Key inclusion criteria
1. Age >/= 18 years

2. De novo stenotic lesion(s) in the superficial femoral artery located at least 1cm
distal to the femoral bifurcation and > 3 cm above the knee joint

3. Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker
Category 2-3

4. Target lesion native reference vessel diameter 4.6 - 6.0 mm by on-line QVA; target
lesion native reference vessel diameter less than 5.0 mm only if lesion residual
stenosis is = 25%

5. Lesion length: up to a maximum that can be covered by one 100mm scaffold

6. Target lesion > 50% stenosis or total occlusion

7. Undisturbed flow to the foot via at least 2 patent infrapopliteal vessel on the
treated side with one vessel free from > 50% stenosis to the ankle joint

8. Patent common and external iliac; TASC A & B lesions may be successfully treated (<30%
residual stenosis) at the time of the index procedure

9. The study patient or the study patient's legal representative has been informed of the
nature of the study, agrees to its provisions and has provided written informed
consent as approved by the Human Research Ethics Committee (HREC) of the respective
clinical site

10. The study patient agrees to comply with all required post-procedure follow-up visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously implanted stent(s) or stent graft(s) in the target lesion

2. Previous endovascular treatment of the target lesion

3. Femoral access in the target limb within 30 days of study procedure

4. Target lesion residual stenosis > 30% after pre-dilatation with nominally sized
balloon

5. Severely calcified lesions as determined by a balloon deformity during dilatation with
a nominally sized balloon inflated at nominal pressure.

6. Acute embolic complication at the trifurcation following pre-dilatation not resolved
by aspiration

7. Target vessel contains acute thrombus

8. Aneurysm in target vessel

9. Critical limb ischemia defined as Rutherford-Becker Category 4-6

10. Intolerance, or allergies which cannot be adequately pre-medicated, to the following:
aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents

11. Life expectancy of less than 12 months

12. Pregnancy or breast feeding (negative pregnancy test within 7 days required in females
of child bearing potential)

13. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)

14. Renal insufficiency (serum creatinine level > 220 µmol/L, or subject is on dialysis)

15. Immunocompromised

16. Active systemic infection or lower limb infection of any nature

17. WBC < 3,000 cells/mm3

18. Myocardial infarction within the past 1 month

19. Stroke within 3 months

20. Un-controlled Atrial-Fibrillation

21. Currently participating in an investigational drug or another device study. Note:
Trials requiring extended follow-up for products that were investigational, but have
since become commercially available, are not considered investigational trials

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Germany
State/province [2] 0 0
Freiburg
Country [3] 0 0
Germany
State/province [3] 0 0
Leipzig
Country [4] 0 0
Germany
State/province [4] 0 0
Rosenheim
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
480 Biomedical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the
treatment of subjects with de novo native superficial femoral artery lesions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01403077
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/ct2/show/NCT01403077