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Sponsors and Collaborators: |
VIVA Physicians Prairie Education and Research Cooperative |
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Information provided by: | VIVA Physicians |
ClinicalTrials.gov Identifier: | NCT00515346 |
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).
Condition | Intervention | Phase |
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Chronic Critical Limb Ischemia Peripheral Vascular Diseases |
Device: Xpert(TM) Self-expanding Transhepatic Biliary Stent System |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 18 Years to 89 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: James D. Joye, DO | 650-969-8600 | jjoye@vivapvd.com |
United States, California | |
VIVA Physicians Inc. | Recruiting |
San Jose, California, United States, 95123 | |
Principal Investigator: James D. Joye, DO |
Principal Investigator: | James D. Joye, DO | VIVA Physicians Inc. |
Study ID Numbers: | G060029 |
Study First Received: | August 9, 2007 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00515346 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CLI Critical Limb Ischemia |
Peripheral Vascular Diseases Vascular Diseases Ischemia |
Pathologic Processes Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Ischemia |