NCT01609621
Completed
Not Applicable
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Cook Group Incorporated
- Enrollment
- 199
- Locations
- 11
- Primary Endpoint
- Technical Success deeming tibial pedal arterial access
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has a totally occluded infrainguinal artery, due to peripheral arterial atherosclerotic disease, for which a previous attempt to cross the occlusion using an antegrade approach was unsuccessful. For institutions where tibiopedal access is performed as a primary standard-of-care procedure, a prior unsuccessful antegrade approach attempt is not required.
Exclusion Criteria
- •Patient will not sign the Informed Consent
Outcomes
Primary Outcomes
Technical Success deeming tibial pedal arterial access
Time Frame: 1 - 4 hours post-procedure.
Study Sites (11)
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