Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery

REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery

Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.

The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic peripheral artery disease of the femoropopliteal artery.

Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be completed within approximately six months of initiating the study.

One group (DES or DEB) will be considered to yield significantly better results of the primary patency rate than the other group at 12 months follow up.

Inclusion Criteria:

• Subject age ≥ 18
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
• Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
• Rutherford category 2-5.
• Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
• Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
• A single target lesion (stenotic areas separated by more than 3 cm with ≤ 30% stenosis might, at the decision of the investigator, be considered as 2 lesions).
• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual assessment.
• Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
• A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

Clinical exclusion criteria

• Inability to obtain informed consent.
• Life expectancy < 12 months.
• Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment).
• Presence of one or more of the following co-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine ≥ 2.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure.
• Any evidence of hemodynamic instability prior to procedure/randomization.
• Coagulopathy or clotting disorders.
• Present or suspected systemic infection or osteomyelitis affecting target limb.
• Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
• Hypersensitivity to nitinol and/or paclitaxel.
• Enrollment into another study.
• Intervention of the target lesion less than 90 days prior of the study procedure.

Anatomic Exclusion Criteria:

• Untreated external iliac artery inflow lesion (study allows for successful treatment prior to study treatment procedures).
• Total occlusion uncrossable by a conventional guidewire.
• Acute occlusive intraluminal thrombosis of the proposed lesion site.
• Evidence of an aneurysm at the target lesion site.
• Perforation in the target vessel as evidenced by the extravasation of contrast.