480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions

Atherosclerosis of Femoral Artery Clinical Trial

— STANCE  

Official title:

A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403077
• Other study ID #: AVI-SFA2011-01
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Lyra Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Femoral Artery
• Superficial Femoral Artery Lesions

Intervention

Device:
• 480 Biomedical Bioresorbable Scaffold System
480 Biomedical Bioresorbable Scaffold System

Locations

Country	Name	City	State
Australia	The Alfred	Melbourne
Austria	Universitäts Klinikum Graz	Graz
Germany	Universitaet Freiburg-Bad Krozingen	Freiburg
Germany	Park Hospital - Heart Center Leipzig	Leipzig
Germany	RoMed Klinikum Rosenheim	Rosenheim
New Zealand	Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
480 Biomedical

Countries where clinical trial is conducted

Australia,  Austria,  Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse events at 6 months post procedure		6 Months
Secondary	Major adverse events at 1 month post procedure		1 Month
Secondary	Major adverse events at 3, 12 months and 24 months post procedure		3, 12 & 24 Months
Secondary	Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure		1, 3, 6, 12, 24 Months
Secondary	Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure		1, 3, 6, 12, 24 Months
Secondary	Walking Impairment Questionnaire		1, 3, 6, 12, 24 Months
Secondary	Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure		1, 3, 6, 12, 24 Months
Secondary	Clinically driven TLR at 3, 12 and 24 months post procedure		3,12, 24 Months