Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
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| ClinicalTrials.gov Identifier: NCT01609621 |
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Recruitment Status :
Completed
First Posted : June 1, 2012
Last Update Posted : November 17, 2020
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Sponsor:
Cook Group Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Peripheral Arterial Disease Critical Limb Ischemia | Device: Retrograde tibiopedal arterial access |
| Study Type : | Observational |
| Actual Enrollment : | 199 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | July 2013 |
| Actual Study Completion Date : | August 2013 |
| Group/Cohort | Intervention/treatment |
|---|---|
| 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. |
Primary Outcome Measures :
- Technical Success deeming tibial pedal arterial access [ Time Frame: 1 - 4 hours post-procedure. ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Terme, Italy, 35031 | |
Sponsors and Collaborators
Cook Group Incorporated
Investigators
| Principal Investigator: | Craig Walker, MD | Terrebone General Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cook Group Incorporated |
| ClinicalTrials.gov Identifier: | NCT01609621 |
| Other Study ID Numbers: |
11-008 |
| First Posted: | June 1, 2012 Key Record Dates |
| Last Update Posted: | November 17, 2020 |
| Last Verified: | November 2020 |
Additional relevant MeSH terms:
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Peripheral Arterial Disease Peripheral Vascular Diseases Ischemia Pathologic Processes Atherosclerosis |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |