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

Peripheral Artery Disease Clinical Trial

— Apollo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539940
• Other study ID #: 4448-06/15
• Status: Completed
• Start date: September 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2020
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV
Angioplasty for revascularization in below-the-knee arteries

Locations

Country	Name	City	State
Germany	Klinikum Altenburger Land GmbH	Altenburg	Thuringia
Germany	Oberlausitz-Kliniken Bautzen	Bautzen	Saxony
Germany	DRK Kliniken Berlin Köpenick	Berlin	Brandenburg
Germany	Städtisches Krankenhaus Dresden-Friedrichstadt	Dresden	Saxony
Germany	SRH-Waldklinikum	Gera	Thuringia
Germany	University Hospital Jena, Radiology	Jena	Thuringia
Germany	Saale-Unstrut Klinikum Naumburg	Naumburg	Thüringen
Germany	MEDINOS Kliniken Sonneberg	Sonneberg	Thuringia
Germany	Kreiskrankenhaus Torgau "J. Kentmann" gGmbH	Torgau
Germany	Heinrich-Braun-Krankenhaus	Zwickau	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Jena University Hospital	Aachen Resonance GmbH, Zentrum für Klinische Studien Jena

Country where clinical trial is conducted

Germany, 

Outcome

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