Please select the eligibility criteria that correspond to the clinical trial below.
Title: Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions
Brief Summary: The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation


Options:
A: Inclusion Criteria:

* Adult patients with PAOD, Rutherford stage 2-5, Occlusion or stenosis \>70% in diameter of at least 3 cm length in the superficial femoral artery and/ or popliteal artery

Exclusion Criteria:

* Acute thrombus or aneurysm in the index limb/ vessel
* Doubts in the willingness or capability of the patient to allow follow up examination
B: Inclusion Criteria:

* Angiographically documented infrapopliteal disease.
* Rutherford category of peripheral arterial disease between class 3 to 6
* Lesion length between 70 to 220 mm
* Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels.

Exclusion Criteria:

* Lesion length \< 70 mm or \> 220 mm.
* Lesions situated in the distal third of the tibial vessels
C: Inclusion Criteria:

* Subject must meet all of the following general inclusion criteria.

  1. Has a Rutherford Clinical Category Score of 1 - 5.
  2. Is willing and capable of complying with all follow-up evaluations at the specified times.
  3. Is ≥ 18 years old.
  4. Provides written informed consent prior to study specific procedures.

Exclusion Criteria:

* The subject must not meet any of the following general exclusion criteria.

  1. Has contraindications listed in any study device IFUs.
  2. Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
  3. Has a hypersensitivity to contrast material that cannot be adequately pretreated.
  4. Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.

  6. Has life expectancy of less than 12 months. 7. Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.

  8. Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.

  9. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.

  10. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.

  11. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.

  12. Has had a previous peripheral bypass affecting the target vessel. 13. Has chronic renal insufficiency with creatinine \> 2.5 mg/L (except patients under chronic renal replacement therapy).

  14. Is unable or unwilling to receive dual anti-platelet therapy. 15. Equipment is unavailable to fulfill study treatments.
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