Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery
Brief Summary: The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.


Options:
A: Inclusion Criteria:

* Patient has signed and dated the informed consent.
* Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
* Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
* Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
* Patient has a resting Ankle Brachial Index (ABI) \<0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a Toe Brachial Index (TBI) \<0.8.
* Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
* Patient agrees to return for x-rays at 6 and 12 months.
* Patient agrees to return for angiography at 12 months.
* Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.

Exclusion Criteria:

* Patient is pregnant or breast-feeding.
* Patient is simultaneously participating in another investigational drug or device study.
* Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
* Patient has had previous stenting of target vessel.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
* Patient lacks at least one patent vessel of runoff with \<50% stenosis throughout its course.
* Patient has untreated angiographically-evident thrombus in the target lesion.

\[Additional criteria may apply.\]
B: Inclusion Criteria:

* age\>18 years
* intermittent claudication (Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation
* angiographic evidence of stent fracture
C: Inclusion Criteria:

* stenosis of the above-the-knee femoropopliteal artery
* appropriate size and location of the lesion

Exclusion Criteria:

* pregnant or breast feeding
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
D: Inclusion Criteria:

General Inclusion Criteria

* Age ≥18 years and ≤85 years
* Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
* Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
* Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
* Life expectancy \>1 year in the Investigator's opinion

General Angiographic Inclusion Criteria

* Reference vessel(s) diameter between 2 and 4 mm
* Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk
* At least one non occluded crural vessel with angiographically documented run-off to the foot either direct or through collaterals

Angiographic Inclusion Criteria for Late Lumen Loss (LLL) assessment

* Angio-target lesion (TL) is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis (DS) ≥70% and a cumulative length ≤100 mm that can be covered by a single IN.PACT Amphirion™ (10 mm balloon landing zone in both edges is mandatory)
* Angio-target lesion (TL) is the only lesion in that vessel (only one Angio-TL per patient is allowed)

Exclusion Criteria:

General Exclusion Criteria

* Patient unwilling or unlikely to comply with Follow-Up schedule
* Planned major index limb amputation

General Angiographic Exclusion Criteria

* Lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space
* Inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA), popliteal arteries with length ≥15 cm
* Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA) and popliteal arteries left untreated
* Previously implanted stent in the target lesions(s)
* Aneurysm in the target vessel
* Acute thrombus in the target limb

General Procedural Exclusion Criteria

* Failure to obtain a \<30% residual stenosis in pre-existing, hemodynamically significant (≥50% diameter stenosis (DS) and \<15 cm length) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. No Drug Eluting Stents (DES) and / or Drug Eluting Balloon (DEB) allowed for the treatment of inflow lesions.
* Failure to cross the TL with a 0.014" guide wire
* Use of alternative therapy, e.g. atherectomy, cutting balloon, laser, radiation therapy, DES as part of the index procedure

ANGIOGRAPHIC cohort General Exclusion Criteria:

- Glomerular Filtration Rate (GFR) \<30 ml/min except for patients with renal end stage disease on chronic haemodialysis

Answer: C