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Local Paclitaxel or Balloon Angioplasty Below the Knee — SAMBA  

Stenosis Clinical Trial

Official title:
Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?

Clinical Trial Summary

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

Clinical Trial Description

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03149913
Study type Interventional
Source Klinikum Rosenheim
Contact Gunnar Tepe, MD
Phone +498031365
Email gunnar.tepe@ro-med.de
Status Recruiting
Phase N/A
Start date December 15, 2016
Completion date July 2020
View Details
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