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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783600
• Other study ID #: FMRP-111125
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2013
• Last updated: August 10, 2016
• Start date: January 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• NanoCross .014 balloon catheter

Locations

Country	Name	City	State
Belgium	OLV Aalst	Alast
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	RZ Heilig Hart Tienen	Tienen

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes