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

F

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

NanoCross .014 balloon catheter
Other group
Description:
NanoCross .014 balloon catheter
Treatment:
Device: NanoCross .014 balloon catheter

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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