ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

Inclusion Criteria

• Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.
• Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).

For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.

If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.

• Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
• Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.
• Subject has life expectancy > 12 months.
• Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).
• Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.

Angiographic Inclusion Criteria

• A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:

Iliac

• Proximal margin of target lesion is ≥ 2.5 cm distal to the aortic bifurcation in common iliac artery
• Distal margin of target lesion is ≥ 1.5 cm proximal to the location of inguinal ligament

SFA

• Proximal margin of target lesion is ≥ 1 cm distal to the common femoral artery bifurcation
• Distal margin of target lesion is ≤ 25 cm distal to the common femoral artery bifurcation
• Vessel diameter from ≥ 5.5 mm to ≤ 6.5 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines
• Target lesion is ≥ 50% DS
• Target lesion length ≤ 50 mm
• Patent inflow artery free from significant lesion (≥ 50% DS and 700,000 cells/mm3; a white blood cell count (WBC) 2.5 mg/dl or >176μmol/L)
• Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
• Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.
• Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
• Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.
• Subject is unable to walk.
• Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, 50% DS) lesion located distal to the target lesion.
• Acute ischemia of the target extremity
• Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
• Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.
• Total occlusion (100% DS) of the ipsilateral inflow artery.
• Angiographic evidence of thrombus in target vessel.
• The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excime