Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.
Completed · Phase 1
Conditions studied: Chronic Critical Limb Ischemia, Peripheral Vascular Diseases
In brief
The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the treatment of documented chronic critical limb ischemia (CLI).
Key facts
- Study ID
- NCT00515346
- Run by
- VIVA Physicians
- People needed
- 120
- Starts
- 2006-07-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2013-12-18
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has documented wound care greater than or equal to 2 weeks prior to enrollment
- Subject understands the duration of the study and its follow up visit requirements
- Female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
- Subject has documented chronic critical limb ischemia in the target limb for two weeks with Rutherford Category 4, 5 or 6
- Subject must have one of 5 approved non-invasive test results of the target limb within two weeks of enrollment.
You may not qualify if…
- Life expectancy of less than 12 months
- Cerebrovascular accident (CVA) or myocardial infarction (MI) within 3 months prior to enrollment
- Inability to walk (with assistance is accepted)
- Previous bypass surgery to target limb less than 30 days prior to study procedure
- Acute thrombus at the lesion site(s)
Where it is running
- VIVA Physicians Inc. — San Jose, California, United States
Full record on ClinicalTrials.gov
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