Treatment for patients with blocked femoropopliteal arteries using a new vascular scaffold

Inclusion Criteria:

* Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)
* Patient with life expectancy \>36 months
* Females of childbearing potential must have negative pregnancy test
* Patient is able to provide informed consent
* Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
* Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed
* Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment
* Reference vessel diameter ≥5.5 mm and ≤6.5 mm
* Target lesion length ≤90 mm
* Target lesion with ≥50% DS
* Inflow artery and popliteal artery free from flow-limiting lesion (DS \<50%)

Exclusion Criteria:

* Hemoglobin \<9.0 g/dL
* WBC \<3,000 cells/mm3
* Platelet count \<80,000 cells/mm3 or \>700,000 cells/mm3
* Acute or chronic renal dysfunction with creatinine \>2.5 mg/dl (176 µmol/L)
* Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT
* A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated
* Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy
* Patient is unable to walk
* Patient has undergone a percutaneous vascular intervention \<30 days prior to the planned index procedure
* Patient is maintained on chronic hemodialysis
* Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).
* Patient has had a myocardial infarction within the previous 30 days of the planned index procedure
* Patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk
* Patient has unstable angina defined as rest angina with ECG changes
* Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment
* Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity
* Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months
* Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
* Patient has ischemic or neuropathic ulcers on either foot
* Patient has undergone minor or major amputation of either lower extremity
* Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent
* Target extremity with an angiographically significant (\>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure
* Acute arterial ischemia of the target extremity
* Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)
* Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy
* Total occlusion (100% DS) of the ipsilateral inflow artery
* Angiographic evidence of thrombus in the target vessel
* The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) \[e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.\]
* Target lesion is within or adjacent to an aneurysm
* Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion
* Target lesion has moderate-to-severe calcification
* Target lesion with \> 30% residual stenosis following pre-dilatation