NCT02539940

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2.6 years

First QC Date

August 17, 2015

Last Update Submit

March 9, 2020

Conditions

Critical Limb IschemiaPeripheral Artery Disease

Keywords

Below-the-knee

Outcome Measures

Primary Outcomes (1)

  • Change of Rutherford Classification

    Change of Rutherford stage to baseline at Follow-up visits

    after 6 and 12 month

Study Arms (1)

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

Interventions

Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SVDEVICE

Angioplasty for revascularization in below-the-knee arteries

Patients with critical limb ischemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

DRK Kliniken Berlin Köpenick

Berlin, Brandenburg, Germany

Location

Oberlausitz-Kliniken Bautzen

Bautzen, Saxony, 02625, Germany

Location

Städtisches Krankenhaus Dresden-Friedrichstadt

Dresden, Saxony, 01067, Germany

Location

Heinrich-Braun-Krankenhaus

Zwickau, Saxony, 08060, Germany

Location

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, 046600, Germany

Location

SRH-Waldklinikum

Gera, Thuringia, 07548, Germany

Location

University Hospital Jena, Radiology

Jena, Thuringia, 07747, Germany

Location

Saale-Unstrut Klinikum Naumburg

Naumburg, Thuringia, 06618, Germany

Location

MEDINOS Kliniken Sonneberg

Sonneberg, Thuringia, 96515, Germany

Location

Kreiskrankenhaus Torgau "J. Kentmann" gGmbH

Torgau, 04860, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31286197DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 17, 2015

First Posted

September 3, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2018

Study Completion

October 1, 2018

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

DE(10)