Clinical trial NCT01609621: Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
Official title: Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Critical Limb Ischemia
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected among those presenting with symptoms of peripheral arterial ischemic disease of the lower extremities and for whom endovascular intervention is deemed appropriate.

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.


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

Primary outcomes:
measure: Technical Success deeming tibial pedal arterial access
timeFrame: 1 - 4 hours post-procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Interventional Technologies, LLC (Tucson Medical Center)
state: Arizona
city: Washington
country: United States
facility: MedStar Health Research Institute (Washington Hospital Center)
state: District of Columbia
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Miami
country: United States
facility: University of Miami (Mount Sinai Hospital)
state: Florida
city: Houma
country: United States
facility: Terrebone Medical Center
state: Louisiana
city: Wyoming
country: United States
facility: Metro Heart and Vascular
state: Michigan
city: Raleigh
country: United States
facility: Rex Hospital, Inc
state: North Carolina
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute, Inc.
state: West Virginia
city: Bad Krozingen
country: Germany
facility: Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH
city: Leipzig
country: Germany
facility: Park-Krankenhaus Leipzig GmbH
city: Abano Terme
country: Italy
facility: Casa Di Cura Abano Terme
Study officials:
affiliation: Terrebone General Medical Center
name: Craig Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker CM, Mustapha J, Zeller T, Schmidt A, Montero-Baker M, Nanjundappa A, Manzi M, Palena LM, Bernardo N, Khatib Y, Beasley R, Leon L, Saab FA, Shields AR, Adams GL. Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study. J Endovasc Ther. 2016 Dec;23(6):839-846. doi: 10.1177/1526602816664768. Epub 2016 Aug 24.