Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01609621
First received: May 16, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease,
Critical Limb Ischemia
Device: Retrograde tibiopedal arterial access

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Technical Success deeming tibial pedal arterial access [ Time Frame: 1 - 4 hours post-procedure. ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Retrograde access 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609621

Locations
United States, Arizona
Interventional Technologies, LLC (Tucson Medical Center)
Tucson, Arizona, United States, 85712
United States, District of Columbia
MedStar Health Research Institute (Washington Hospital Center)
Washington, District of Columbia, United States, 20010
United States, Florida
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
University of Miami (Mount Sinai Hospital)
Miami, Florida, United States, 33140
United States, Louisiana
Terrebone Medical Center
Houma, Louisiana, United States, 70360
United States, Michigan
Metro Heart and Vascular
Wyoming, Michigan, United States, 49519
United States, North Carolina
Rex Hospital, Inc
Raleigh, North Carolina, United States, 27607
United States, West Virginia
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, United States, 25304
Germany
Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, Germany, 79189
Park-Krankenhaus Leipzig GmbH
Leipzig, Germany, 04289
Italy
Casa Di Cura Abano Terme
Abano Herme, Italy, 35031
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Craig Walker, MD Terrebone General Medical Center
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01609621     History of Changes
Other Study ID Numbers: 11-008
Study First Received: May 16, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014