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A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).

Chronic Total Occlusion Clinical Trial

Clinical Trial Summary

Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires revascularization.

Clinical Trial Description

This is an open label, single center, prospective, first in man pilot study in which the investigational device, NitiLoop micro-catheter, will be tested in up to 15 patients with symptomatic peripheral arterial occlusive disease scheduled to undergo CTO in an anterograde approach. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02358629
Study type Interventional
Source Nitiloop Ltd.
Contact
Status Completed
Phase N/A
Start date February 2015
Completion date July 2016
View Details
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