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

Completed

• Conditions: Critical Limb Ischemia; Peripheral Artery Disease
• Interventions: Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV

• Registration Number: NCT02539940
• Lead Sponsor: Jena University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2015-08-17
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-03
• Primary Completion: 2018-04
• Study Completion: 2018-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with critical limb ischemia	Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV	Patients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon).

Primary Outcome Measures

Name	Time	Method
Change of Rutherford Classification	after 6 and 12 month	Change of Rutherford stage to baseline at Follow-up visits

Trial Locations

Locations (10)

University Hospital Jena, Radiology; 🇩🇪 Jena, Thuringia, Germany

MEDINOS Kliniken Sonneberg; 🇩🇪 Sonneberg, Thuringia, Germany

Klinikum Altenburger Land GmbH; 🇩🇪 Altenburg, Thuringia, Germany

SRH-Waldklinikum; 🇩🇪 Gera, Thuringia, Germany

Oberlausitz-Kliniken Bautzen; 🇩🇪 Bautzen, Saxony, Germany

DRK Kliniken Berlin Köpenick; 🇩🇪 Berlin, Brandenburg, Germany

Heinrich-Braun-Krankenhaus; 🇩🇪 Zwickau, Saxony, Germany

Städtisches Krankenhaus Dresden-Friedrichstadt; 🇩🇪 Dresden, Saxony, Germany

Saale-Unstrut Klinikum Naumburg; 🇩🇪 Naumburg, Thüringen, Germany

Kreiskrankenhaus Torgau "J. Kentmann" gGmbH; 🇩🇪 Torgau, Germany