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Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609621
First Posted: June 1, 2012
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
May 16, 2012
June 1, 2012
December 20, 2016
May 2012
July 2013   (Final data collection date for primary outcome measure)
Technical Success deeming tibial pedal arterial access [ Time Frame: 1 - 4 hours post-procedure. ]
Same as current
Complete list of historical versions of study NCT01609621 on ClinicalTrials.gov Archive Site
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Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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.
  • Peripheral Arterial Disease
  • Critical Limb Ischemia
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.
Retrograde access
Intervention: Device: Retrograde tibiopedal arterial access
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. Epub 2016 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
August 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   United States
 
 
NCT01609621
11-008
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Cook Group Incorporated
Cook Group Incorporated
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Principal Investigator: Craig Walker, MD Terrebone General Medical Center
Cook Group Incorporated
December 2016