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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Flanders Medical Research Program
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01783600
First received: January 25, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Device: NanoCross .014 balloon catheter
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

Resource links provided by NLM:


Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • primary Patency [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Technical success [ Time Frame: Day 0 (=procedure date) ] [ Designated as safety issue: No ]
    Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

  • Hemodynamic primary patency [ Time Frame: 1 and 6 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Limb-salvage rate [ Time Frame: 1, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    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).

  • Primary assisted patency rate [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Secondary patency rate [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Target lesion revascularization [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ] [ Designated as safety issue: No ]
    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.

  • Clinical success at follow-up [ Time Frame: 1 day and 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Number of patients with Serious Adverse Events (SAE) as a measure of safety [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NanoCross .014 balloon catheter
NanoCross .014 balloon catheter
Device: NanoCross .014 balloon catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783600

Contacts
Contact: Tineke Bonnarens +32 52 25 28 22 office@fmrp.be
Contact: Bavo Van Puyvelde +32 52 25 28 22 office@fmrp.be

Locations
Belgium
OLV Aalst Recruiting
Alast, Belgium, 9300
Contact: Lieven Maene, MD    +32 53 72 46 99    lmaene@hotmail.com   
Principal Investigator: Lieven Maene, MD         
Sub-Investigator: Roel Beelen, MD         
Imelda Hospital Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters, MD    +32 15 50 61 97    pztrick.peeters@imelda.be   
Contact: Wendy Janssens    +32 015 50 61 82    wendy.janssens@fmrp.be   
Principal Investigator: Patrick Peeters, MD         
Sub-Investigator: Jurgen Verbist, MD         
AZ Sint-Blasius Recruiting
Dendermonde, Belgium, 9200
Contact: Marc Bosiers, MD    +32 52 25 27 35    marc.bosiers@telenet.be   
Principal Investigator: Marc Bosiers, MD         
Sub-Investigator: Koen Deloose, MD         
Sub-Investigator: Joren Callaert, MD         
RZ Heilig Hart Tienen Recruiting
Tienen, Belgium, 3300
Contact: Koen Keirse, MD    +32 16 80 99 72    keirsekoen@hotmail.com   
Contact: Lies Vanermen    +32 16 80 99 72    vaatheelkunde@rztienen.be   
Principal Investigator: Koen Keirse, MD         
Sponsors and Collaborators
Flanders Medical Research Program
  More Information

No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01783600     History of Changes
Other Study ID Numbers: FMRP-111125
Study First Received: January 25, 2013
Last Updated: August 5, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Flanders Medical Research Program:
Peripheral Arterial Disease
Infrapopliteal lesions
balloon catheter

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014