NCT00546845

Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cronic Limb Ishemia
• Intervention

Interventions

Type	Name	Description
DEVICE	Balloon angioplasty	Balloon angioplasty. Only stent if PTA fails
DEVICE	Use of self-expanding Expert stent	Nitinol stent

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-03-01
• Completion: 2014-06-01
• First posted: 2007-10-19
• Last updated: 2011-08-08

Locations

1 site across 1 country: Germany