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Clinical Trials/NCT01609621
NCT01609621
Completed
Not Applicable

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Cook Group Incorporated11 sites in 3 countries199 target enrollmentMay 2012

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
August 2013
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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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