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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

May 16, 2012
September 30, 2013
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. ] [ Designated as safety issue: No ]
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.

Not Provided
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
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*   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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy
 
NCT01609621
11-008
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Craig Walker, MD Terrebone General Medical Center
Cook
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP