Clinical trial NCT01403077: 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
Official title: A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superficial Femoral Artery Lesions
Atherosclerosis of Femoral Artery
Keywords: Superficial femoral artery
Peripheral arterial disease
Atherosclerosis
Intermittent Claudication
Vascular Diseases
Cardiovascular Diseases
Lead sponsor: Lyra Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse events at 6 months post procedure
timeFrame: 6 Months
Secondary outcomes:
measure: Major adverse events at 1 month post procedure
timeFrame: 1 Month
measure: Major adverse events at 3, 12 months and 24 months post procedure
timeFrame: 3, 12 & 24 Months
measure: Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure
timeFrame: 1, 3, 6, 12, 24 Months
measure: Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure
timeFrame: 1, 3, 6, 12, 24 Months
measure: Walking Impairment Questionnaire
timeFrame: 1, 3, 6, 12, 24 Months
measure: Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure
timeFrame: 1, 3, 6, 12, 24 Months
measure: Clinically driven TLR at 3, 12 and 24 months post procedure
timeFrame: 3,12, 24 Months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred
city: Graz
country: Austria
facility: Universitäts Klinikum Graz
city: Freiburg
country: Germany
facility: Universitaet Freiburg-Bad Krozingen
city: Leipzig
country: Germany
facility: Park Hospital - Heart Center Leipzig
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: