Critical Limb Ischemia, Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICERetrograde 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.
Sponsors
Cook Group Incorporated
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical Success deeming tibial pedal arterial access | 1 - 4 hours post-procedure. |
Countries
Germany, Italy, United States
Outcome results
None listed