Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Cook Group Incorporated199 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

199

Conditions

Peripheral Arterial Disease Critical Limb Ischemia

Interventions

Retrograde tibiopedal arterial accessDEVICE

Retrograde, percutaneous arterial access of vessels at or below the tibioperoneal trunk, using a 21 gage needle or micropuncture introducer set, to facilitate crossing and treatment (e.g., angioplasty, stenting, atherectomy) of occlusive arterial lesions in the lower limb.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (11)

Interventional Technologies, LLC (Tucson Medical Center)

Tucson, Arizona, United States

MedStar Health Research Institute (Washington Hospital Center)

Washington D.C., District of Columbia, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Technical Success deeming tibial pedal arterial access

Time frame: 1 - 4 hours post-procedure.

Data from ClinicalTrials.gov

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