Clinical trial NCT02539940: Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Official title: A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Peripheral Artery Disease
Keywords: Below-the-knee
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Zentrum für Klinische Studien Jena
name: Aachen Resonance GmbH
First posted: 2015-09-03
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients in Germany who undergo treatment with the ELUTAX SV-DEB that is applied for treatment of peripheral arterial disease (PAD) in below-the-knee vessels.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Rutherford Classification
timeFrame: after 6 and 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Köpenick
state: Brandenburg
city: Bautzen
country: Germany
facility: Oberlausitz-Kliniken Bautzen
state: Saxony
city: Dresden
country: Germany
facility: Städtisches Krankenhaus Dresden-Friedrichstadt
state: Saxony
city: Zwickau
country: Germany
facility: Heinrich-Braun-Krankenhaus
state: Saxony
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
state: Thuringia
city: Gera
country: Germany
facility: SRH-Waldklinikum
state: Thuringia
city: Jena
country: Germany
facility: University Hospital Jena, Radiology
state: Thuringia
city: Sonneberg
country: Germany
facility: MEDINOS Kliniken Sonneberg
state: Thuringia
city: Naumburg
country: Germany
facility: Saale-Unstrut Klinikum Naumburg
state: Thüringen
city: Torgau
country: Germany
facility: Kreiskrankenhaus Torgau "J. Kentmann" gGmbH
Study officials:
References:
citation: Teichgraber U, Lehmann T, Thieme M, Wahl KU, Stelzner C, Bormann A, Gotz L, Kroessner T, Boden H, Maiwald L, Aschenbach R. Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1380-1390. doi: 10.1007/s00270-019-02279-6. Epub 2019 Jul 8.