Peripheral Vascular Diseases Clinical Trial
— XCELLOfficial title:
Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs
Verified date | December 2013 |
Source | VIVA Physicians |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VIVA Physicians Inc. | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
VIVA Physicians | Prairie Education and Research Cooperative |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amputation free survival at 12 months in the target limb. Amputation for the primary endpoint is defined as a major, unplanned, amputation of the target limb through the 12 month visit where prosthesis is required for standing or walking. | 1 year | No | |
Secondary | Assess improvement in wound healing; assess restenosis; measure target lesion revascularization to maintain patency at 12 months; measure ankle/brachial improvement level; assess stent integrity; characterize improvement in health related quality of life | 2 years | No |
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