Peripheral Vascular Diseases Clinical Trial
Official title:
Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs
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).
Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million
Americans annually. The diabetic population is particularly prone to the most severe
clinical problems associated with PAD and the amputation rate amongst such patients is
elevated five-fold. It has been shown that patients who undergo amputation for PAD/CLI have
a much higher mortality rate in the months that follow.
Despite medical advances in the fields of pharmacology and wound care, the vast majority of
patients who present with CLI will ultimately require amputation in the absence of improved
blood flow. Recently, much attention has been directed towards less invasive endovascular
solutions for treating patients with CLI. This study will evaluate approximately 140
subjects with Rutherford Class IV-VI PAD in a multi-center study in order to accurately
estimate limb salvage rates for this treatment.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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||
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