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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: NanoCross .014 balloon catheter

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Alast, Belgium, 9300
    • OLV Aalst
  • Bonheiden, Belgium, 2820
    • Imelda Hospital
  • Dendermonde, Belgium, 9200
    • AZ Sint-Blasius
  • Tienen, Belgium, 3300
    • RZ Heilig Hart Tienen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NanoCross .014 balloon catheter; NanoCross .014 balloon catheter	Device: NanoCross .014 balloon catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: February 1, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Estimate): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: balloon catheter; Peripheral Arterial Disease; Infrapopliteal lesions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FMRP-111125