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Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment — Apollo  

Peripheral Artery Disease Clinical Trial

Official title:
A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

Clinical Trial Summary

The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels

Clinical Trial Description

The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02539940
Study type Observational
Source Jena University Hospital
Contact
Status Completed
Phase
Start date September 2015
Completion date October 2018
View Details
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