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.
XCELL
Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs
1 other identifier
interventional
120
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 18, 2013
December 1, 2013
3.4 years
August 9, 2007
December 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVA Physicianslead
- Prairie Education and Research Cooperativecollaborator
Study Sites (1)
VIVA Physicians Inc.
San Jose, California, 95123, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D. Joye, DO
VIVA Physicians Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 13, 2007
Study Start
July 1, 2006
Primary Completion
December 1, 2009
Study Completion
September 1, 2011
Last Updated
December 18, 2013
Record last verified: 2013-12