NCT02539940

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Critical Limb Ischemia
• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV	Angioplasty for revascularization in below-the-knee arteries

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-04-01
• Completion: 2018-10-01
• First posted: 2015-09-03
• Last updated: 2020-03-10

Locations

10 sites across 1 country: Germany