Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH, Bad Krozingen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrograde tibiopedal arterial access

Device

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.

Primary outcomes

Technical Success deeming tibial pedal arterial access

Time frame: 1 - 4 hours post-procedure.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 1, 2012
Registry last updated: Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed