PREVENT: Promus BTK

PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK

This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated.

In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.

General Inclusion Criteria:

• Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life-expectancy of at least 12 months
• The treating physician consider the patient eligible for below-the-knee treatment with the PROMUS ELEMENT Stent (Boston Scientific) and PROMUS ELEMENT PLUS Stent (Boston Scientific)
• Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic Inclusion Criteria:

• Single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal arteries, including the tibiofibular trunk
• A maximum of two focal target lesions in one or more infrapopliteal vessels
• Length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be implanted
• Target vessel diameter visually estimated to be >2.5mm and <4.0mm
• Guidewire and delivery system successfully traversed lesion

General Exclusion Criteria:

• Patient refusing treatment
• Previously implanted stent in the artery to be treated
• Failed PTA of target lesion/vessel less than 3 months prior to study procedure
• The reference segment diameter is not suitable for the available stent design
• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
• Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
• Aneurysm in the target vessel
• Patient presents with renal failure, evidenced by a serum creatinine level >2.0mg/dL
• Patient presents with platelet levels above or below normal range
• Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Any previously known coagulation disorder, including hypercoagulability
• Contraindication to anticoagulation or antiplatelet therapy
• Known allergies to stent or stent components
• Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
• Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Currently participating in another clinical research trial
• Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
• Target lesion access not performed by transfemoral approach.