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Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study

NCT00546845 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2011-08-08

No results posted yet for this study

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

DEVICE

Balloon angioplasty

Balloon angioplasty. Only stent if PTA fails

DEVICE

Use of self-expanding Expert stent

Nitinol stent

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Gunnar Tepe, MD · University Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-03-31
Completion
2014-06-30

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 NCT00546845 on ClinicalTrials.gov