NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to
 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective,
 non-randomised, controlled investigation for the treatment of patients with critical limb
 ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the
 level of the below-the-knee arteries.
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

 -  Patient is eligible for treatment with the NanoCrossTM .014 balloon catheter
 (Covidien)

 -  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

 -  De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries,suitable
 for endovascular therapy

 -  Total target lesion length minimally 100mm

 -  Target vessel diameter visually estimated to be >1.5mm and <4.0mm

 -  Guidewire and delivery system successfully traversed lesion

 -  At least one non-occluded crural artery with angiographically documented run- off to
 the foot.

 Exclusion Criteria:

 -  Patient refusing treatment

 -  The reference segment diameter is not suitable for the available balloon 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

 -  Target lesion has severe calcification as determined by physician's discretion

 -  Non-atherosclerotic 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 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.