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

Jena University Hospital166 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

166

Conditions

Critical Limb Ischemia Peripheral Artery Disease

Interventions

Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SVDEVICE

Angioplasty for revascularization in below-the-knee arteries

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB * Age ≥ 18 years * Signed informed consent * documented Critical Limb Ischemia (CLI) in the target limb prior to the study * Rutherford Category 4, 5 or 6 * ≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion * Patent inflow artery * Target vessel(s) diameter between 2 and 4 mm * Target vessel(s) reconstitute(s) at or above the ankle Exclusion Criteria: * Life expectancy below 50% within the next 12 months (as judged by the investigator) * Planned major index limb amputation * Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis) * Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed) * Patient unwilling or unlikely to comply with follow-up schedule

Locations (10)

DRK Kliniken Berlin Köpenick

Berlin, Brandenburg, Germany

Oberlausitz-Kliniken Bautzen

Bautzen, Saxony, Germany

Städtisches Krankenhaus Dresden-Friedrichstadt

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Change of Rutherford Classification

Change of Rutherford stage to baseline at Follow-up visits

Time frame: after 6 and 12 month

Data from ClinicalTrials.gov

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