Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System

An Evaluation of the 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System in the Treatment of de Novo SFA Lesions

An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease.

The STANZA DRS system is comprised of a controlled release paclitaxel-eluting bioresorbable scaffold and a delivery system used in the treatment of superficial femoral artery disease.

Inclusion Criteria

1. Age > 18 years.
2. De novo stenotic lesion(s) in the superficial femoral artery located at least 1 cm distal to the femoral bifurcation and > 5 cm above the joint space of the knee.
3. Patient has symptomatic intermittent claudication affecting at least the target leg (Rutherford Class 2-3). Patients should have first received conservative medical management of their symptoms prior to study inclusion. The symptoms can be bilateral.
4. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
5. The study patient agrees to comply with all required post-procedure study requirements.

Baseline Inclusion Criteria

1. Reference vessel diameter (RVD) 5.0 -6.0 mm measured by an objective measurement such as online Quantitative Vessel Analysis (QVA).
2. Target lesion length ≤ 90 mm; total occlusion length < 40 mm.
3. Target lesion has a ≥70% diameter stenosis.
4. Angiographic evidence of at least one runoff vessel to the ankle/foot without hemodynamically significant stenosis (>50% diameter stenosis) that does not require any treatment within 3 months of the index procedure.
5. Procedural access can be accomplished via contralateral vascular access or if antegrade access no closure device can be utilized and closure has to occur via manual pressure.
6. Patent common and external iliac: TASC A & B iliac lesions may be treated at the time of index procedure (before treatment of the target lesion) if residual stenosis is ≤30%.

Exclusion Criteria

1. Previous vascular surgery/endovascular treatment of the target lesion.
2. Re-vascularization of target vessel within 30 days of study procedure.
3. Critical limb ischemia defined as Rutherford Becker Category 4-6.
4. Known coagulation disorders or intolerance or allergies to aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents which cannot be adequately pre-medicated.
5. Life expectancy ≤12 months.
6. Planned procedure that necessitates the discontinuation of antiplatelet medications used in conjunction with the investigational device within 3 months post-procedure.
7. Inability to walk due to orthopedic or other nonvascular complications.
8. Pregnancy or breast feeding or patient desires to become pregnant.
9. Non-atherosclerotic lesion (e.g. vasculitis).
10. Renal insufficiency (serum creatinine level > 220 µmol/L or > 2.5 mg/dl, or patient is on dialysis).
11. Patient has medical condition(s) which could affect study assessments or may adversely affect the safety and/or success of the study treatment.
12. Active systemic infection or lower limb infection of any nature.
13. White Blood Cells (WBC) ≤ 3,000 cells/mm3.
14. Myocardial infarction within 30 days prior to the study procedure.
15. Stroke within 90 days prior to the study procedure.
16. Uncontrolled atrial fibrillation.
17. 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.
18. Prior use of paclitaxel-eluting products in the target limb less than 6 months prior to index procedure.
19. Patient has known unstable angina.

Baseline Exclusion Criteria

1. Target lesion treatment with a drug eluting balloon.
2. Target lesion treatment with atherectomy, laser, or cryoplasty (use of a cutting or scoring balloon is permitted prior to scaffold implantation only).
3. Suspicion for or evidence of subintimal passage of guidewire.
4. Severely calcified lesion(s).
5. Target lesion which, based on two angiographic orthogonal views, exhibit a persistent balloon deformity during pre-dilatation with a nominally sized balloon.
6. Target vessel (superficial femoral artery) has an angiographically significant (> 50% diameter stenosis) lesion located distally or proximally to the target lesion.
7. Acute embolic complication following pre-dilatation.
8. Target vessel contains an acute thrombus.
9. Aneurysm in target vessel or co-existing clinically significant aneurysmal disease of the abdominal aorta, iliac or popliteal arteries.
10. Intervention in the infra-inguinal arteries outside of the target lesion.
11. Planned procedure within 30 days after the index procedure.
12. Positive pregnancy test for females of child bearing potential.