Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Cook Group

Status: Completed

Conditions: Critical Limb Ischemia; Peripheral Arterial Disease

Treatments: Device: Retrograde tibiopedal arterial access

Study type: Observational

Funder types: Industry

Identifiers

NCT01609621

11-008

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

199 participants in 1 patient group

Retrograde access

Treatment:

Device: Retrograde tibiopedal arterial access