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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02539940

Acronym

Apollo

Enrollment

166

Registered

2015-09-03

Start date

2015-09-30

Completion date

2018-10-31

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Peripheral Artery Disease

Keywords

Below-the-knee

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.

Interventions

DEVICEAngioplasty Paclitaxel-eluted balloon catheter ELUTAX SV

Angioplasty for revascularization in below-the-knee arteries

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Rutherford Classification	after 6 and 12 month	Change of Rutherford stage to baseline at Follow-up visits

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026