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Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis

NCT01398033 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-08-05

No results posted yet for this study

Summary

There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. The indications for stent placement are poor primary results following percutaneous transluminal angioplasty or evidence of a flow-limiting dissection. The primary success rate after a stent placement is between 80% and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis reoccurs in 70% to 80% of cases.

The aim of this study is to analyse the primary success and the long term results of angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in the treatment of in-stent restenosis of lower limb arteries.

Conditions

  • In-stent Stenosis of Infrapopliteal Arteries

Interventions

DEVICE

paclitaxel-coated balloon

Balloon is coated with paclitaxel in a concentration of 3µg/mm2.

DEVICE

non-coated balloon

percutaneous transluminal angioplasty with a non-coated balloon

Sponsors & Collaborators

  • University Heart Center Freiburg - Bad Krozingen

    collaborator OTHER

  • Herz-Zentrums Bad Krozingen

    lead OTHER

Principal Investigators

  • Aljoscha Rastan, M.D. · Herzzentrum Bad Krozingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-09-30
Completion
2014-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398033 on ClinicalTrials.gov