Clinical trial NCT01783600: NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
Official title: NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Infrapopliteal lesions
balloon catheter
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2013-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: primary Patency
timeFrame: 12 Months
Secondary outcomes:
measure: Technical success
timeFrame: Day 0 (=procedure date)
measure: Hemodynamic primary patency
timeFrame: 1 and 6 months follow-up
measure: Limb-salvage rate
timeFrame: 1, 6 and 12 months follow-up
measure: Primary assisted patency rate
timeFrame: 1, 6, 12-month follow-up
measure: Secondary patency rate
timeFrame: 1, 6, 12-month follow-up
measure: Target lesion revascularization
timeFrame: 1 day, 1 month, 6 month and 12 month follow-up
measure: Clinical success at follow-up
timeFrame: 1 day and 1, 6, 12-month follow-up
measure: Number of patients with Serious Adverse Events (SAE) as a measure of safety
timeFrame: 1 day, 1 month, 6 month and 12 month follow-up
Other outcomes:
Locations:
city: Alast
country: Belgium
facility: OLV Aalst
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Tienen
country: Belgium
facility: RZ Heilig Hart Tienen
Study officials:
References: