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

Jena University Hospital

Status: Completed

Conditions: Peripheral Artery Disease; Critical Limb Ischemia

Treatments: Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02539940

4448-06/15

Details and patient eligibility

About

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

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

166 participants in 1 patient group

Patients with critical limb ischemia

Description:

Patients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon).

Treatment:

Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV