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

A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV

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 Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Germany
  • Torgau, Germany, 04860
    • Kreiskrankenhaus Torgau "J. Kentmann" gGmbH
  • Brandenburg
    • Berlin, Brandenburg, Germany
      • DRK Kliniken Berlin Köpenick
  • Saxony
    • Bautzen, Saxony, Germany, 02625
      • Oberlausitz-Kliniken Bautzen
    • Dresden, Saxony, Germany, 01067
      • Städtisches Krankenhaus Dresden-Friedrichstadt
    • Zwickau, Saxony, Germany, 08060
      • Heinrich-Braun-Krankenhaus
  • Thuringia
    • Altenburg, Thuringia, Germany, 046600
      • Klinikum Altenburger Land GmbH
    • Gera, Thuringia, Germany, 07548
      • SRH-Waldklinikum
    • Jena, Thuringia, Germany, 07747
      • University Hospital Jena, Radiology
    • Sonneberg, Thuringia, Germany, 96515
      • MEDINOS Kliniken Sonneberg
  • Thüringen
    • Naumburg, Thüringen, Germany, 06618
      • Saale-Unstrut Klinikum Naumburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with critical limb ischemia; Patients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon).	Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV; Angioplasty for revascularization in below-the-knee arteries

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Zentrum für Klinische Studien Jena; Aachen Resonance GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (ESTIMATE): September 3, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Below-the-knee
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 4448-06/15