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

NCT01783600 | Completed Phase 4 DMC

• 1 other identifier: FMRP-111125
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Infrapopliteal lesions; balloon catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Technical success

  Day 0 (=procedure date)

• Hemodynamic primary patency

  1 and 6 months follow-up

• Limb-salvage rate

  1, 6 and 12 months follow-up

• Primary assisted patency rate

  1, 6, 12-month follow-up

• Secondary patency rate

  1, 6, 12-month follow-up

Study Arms (1)

NanoCross .014 balloon catheter

OTHER

NanoCross .014 balloon catheter

Device: NanoCross .014 balloon catheter

Interventions

NanoCross .014 balloon catheter DEVICE

NanoCross .014 balloon catheter

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

OLV Aalst

Alast, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

RZ Heilig Hart Tienen

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

BE (4)