Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Completed

• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia
• Interventions: Device: Retrograde tibiopedal arterial access

• Registration Number: NCT01609621
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrograde access	Retrograde tibiopedal arterial access	-

Primary Outcome Measures

Name	Time	Method
Technical Success deeming tibial pedal arterial access	1 - 4 hours post-procedure.

Trial Locations

Locations (11)

Casa Di Cura Abano Terme; 🇮🇹 Abano Terme, Italy

Park-Krankenhaus Leipzig GmbH; 🇩🇪 Leipzig, Germany

First Coast Cardiovascular Institute; 🇺🇸 Jacksonville, Florida, United States

Metro Heart and Vascular; 🇺🇸 Wyoming, Michigan, United States

Rex Hospital, Inc; 🇺🇸 Raleigh, North Carolina, United States

Interventional Technologies, LLC (Tucson Medical Center); 🇺🇸 Tucson, Arizona, United States

Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH; 🇩🇪 Bad Krozingen, Germany

MedStar Health Research Institute (Washington Hospital Center); 🇺🇸 Washington, District of Columbia, United States

University of Miami (Mount Sinai Hospital); 🇺🇸 Miami, Florida, United States

CAMC Health Education and Research Institute, Inc.; 🇺🇸 Charleston, West Virginia, United States

Terrebone Medical Center; 🇺🇸 Houma, Louisiana, United States