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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrograde access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde tibiopedal arterial access | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success deeming tibial pedal arterial access | 1 - 4 hours post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Craig Walker, MD | Terrebone General Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Interventional Technologies, LLC (Tucson Medical Center) | Tucson | Arizona | 85712 | United States | ||
| MedStar Health Research Institute (Washington Hospital Center) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27558463 | Derived | 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. doi: 10.1177/1526602816664768. Epub 2016 Aug 24. |
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|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| University of Miami (Mount Sinai Hospital) | Miami | Florida | 33140 | United States |
| Terrebone Medical Center | Houma | Louisiana | 70360 | United States |
| Metro Heart and Vascular | Wyoming | Michigan | 49519 | United States |
| Rex Hospital, Inc | Raleigh | North Carolina | 27607 | United States |
| CAMC Health Education and Research Institute, Inc. | Charleston | West Virginia | 25304 | United States |
| Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH | Bad Krozingen | 79189 | Germany |
| Park-Krankenhaus Leipzig GmbH | Leipzig | 04289 | Germany |
| Casa Di Cura Abano Terme | Abano Terme | 35031 | Italy |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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