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

Flanders Medical Research Program

Status and phase

Completed

Phase 4

Conditions

Peripheral Arterial Disease

Treatments

Device: NanoCross .014 balloon catheter

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01783600

FMRP-111125

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.