NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

Study Overview
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Brief Summary
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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.

Official Title
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NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: NanoCross .014 balloon catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NanoCross .014 balloon catheter<br>NanoCross .014 balloon catheter | Device: NanoCross .014 balloon catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary Patency | Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 12-month follow-up | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%. | Day 0 (=procedure date) | 
| Hemodynamic primary patency | Hemodynamic primary patency rate at 1 and 6-month follow-up. Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up. | 1 and 6 months follow-up | 
| Limb-salvage rate | Limb-salvage rate at all follow-up visits, defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot). | 1, 6 and 12 months follow-up | 
| Primary assisted patency rate | Primary assisted patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure. | 1, 6, 12-month follow-up | 
| Secondary patency rate | Secondary patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion. | 1, 6, 12-month follow-up | 
| Target lesion revascularization | Target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge. | 1 day, 1 month, 6 month and 12 month follow-up | 
| Clinical success at follow-up | Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification. | 1 day and 1, 6, 12-month follow-up | 
| Number of patients with Serious Adverse Events (SAE) as a measure of safety | Serious adverse events as defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization | 1 day, 1 month, 6 month and 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Infrapopliteal lesions, balloon catheter