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NCT01609621 Clinical Trial

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Peripheral Arterial Disease Clinical Trial

Official title:
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01609621
Other study ID # 11-008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date August 2013

Study information
Verified date November 2020
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 199
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Retrograde tibiopedal arterial access
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.

Locations
Country Name City State
Germany Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH Bad Krozingen
Germany Park-Krankenhaus Leipzig GmbH Leipzig
Italy Casa Di Cura Abano Terme Abano Terme
United States CAMC Health Education and Research Institute, Inc. Charleston West Virginia
United States Terrebone Medical Center Houma Louisiana
United States First Coast Cardiovascular Institute Jacksonville Florida
United States University of Miami (Mount Sinai Hospital) Miami Florida
United States Rex Hospital, Inc Raleigh North Carolina
United States Interventional Technologies, LLC (Tucson Medical Center) Tucson Arizona
United States MedStar Health Research Institute (Washington Hospital Center) Washington District of Columbia
United States Metro Heart and Vascular Wyoming Michigan

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Technical Success deeming tibial pedal arterial access 1 - 4 hours post-procedure.
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