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Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study — XXS  

Intervention Clinical Trial

Official title:
Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee

Clinical Trial Summary

This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Patients will be eligible for randomization if they are over 18 years old, if they undergo percutaneous catheter revascularization of an artery below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two vessels may be treated in this study. All lesions greater than 50% in the below the knee artery region have to be treated either with PTA or stenting according to the randomization.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00546845
Study type Interventional
Source University Hospital Tuebingen
Contact Gunnar Tepe, MD
Phone 49 7071 2983371
Email gunnar.tepe@med.uni-tuebingen.de
Status Recruiting
Phase Phase 4
Start date September 2007
Completion date June 2014
View Details
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