Please select the eligibility criteria that correspond to the clinical trial below.
Title: Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis
Brief Summary: The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further angiographic and clinical efficacy and various safety criteria.


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:

* Age: \> or equal to 18 years and \< or equal to 85 years
* Documented ischemia with Rutherford classification 2, 3, or 4
* Target lesion in the SFA and/or PPA
* Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:

  1. 70 - 99% occlusion by visual estimate with lesion length \> or equal to 4 cm and \< or equal to 18 cm
  2. 100% occlusion by visual estimate with lesion length \< or equal to 10 cm
  3. Combination lesions must have a total lesion length of \> or equal to 4 cm and \< or equal to 18 cm with an occluded segment that is \< or equal to 10 cm (by visual estimate)
* Target vessel diameter \> or equal to 4 mm and \< or equal to 7 mm
* Angiographic evidence of adequate distal run-off to the ankle
* Able to walk without assistive devices

Exclusion Criteria:

* Stroke or heart attack within 3 months prior to enrollment
* Enrolled in another investigational drug, device or biologic study
* Any surgical procedure or intervention performed within 30 days prior to or post index procedure
* SFA or PPA disease in the opposite leg that requires treatment at the index procedure
* Failure to successfully cross the target lesion
* Angiographic evidence of severe calcification
* Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
* Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
* Chronic kidney disease
C: Inclusion Criteria:

1. Subject has provided written informed consent.
2. Subject is willing and able to comply with follow-up evaluations.
3. Subject is ≥ 18 years old.
4. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
5. A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
6. Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.
7. Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
8. Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before the index procedure, with a maximum residual stenosis of 30% per visual assessment.
9. At least one non-occluded crural vessel with angiographically documented run-off to the foot.
10. Successful wire crossing of the lesion.

Exclusion Criteria:

1. Flow-limiting (\> 50% DS) inflow lesion proximal to target lesion, left untreated.
2. Failure to obtain \<30% residual stenosis in a pre-existing haemodynamically significant (\>50% DS) inflow lesion (DEB or DES not allowed for the treatment of inflow lesions).
3. Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
4. Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
5. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
6. Previous bypass surgery of target vessel.
7. Previously implanted stent in target lesion.
8. Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.
9. Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.
10. Subject with acute MI ≤ 3 months.
11. Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.
12. Phenprocoumon intake, except for patients who are treated for Arterial Fibrillation. For these patients Phenprocoumon treatment can be interrupted and re-started after treatment with Dual Antiplatelet Therapy for 4 weeks post procedure.
13. Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.
14. Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).
15. Co- morbid conditions limiting life expectancy ≤ 1 year.
16. Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.
17. Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.
18. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
D: 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

Answer: A