The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).
This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing endovascular treatment of lesions within or extending into the target area (10 cm above the medial epicondyle to the digital arteries). This includes disease in a vessel located within or extending into the distal superficial femoral artery (SFA), popliteal (POP), tibial peroneal trunk (TPT), anterior tibial (AT), posterior tibial (PT), and peroneal tibial (PR) arteries.
Study Type
OBSERVATIONAL
Enrollment
1,204
All FDA-cleared endovascular PAD treatments
Procedural Success of Endovascular PAD Treatment(s)
Final post-procedural result of \<50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Lesion Success of Endovascular PAD Treatment(s)
Final post-procedural result of \<50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years. 1- and 3-year MAE is composed of: * Death within 30 days of index procedure * Unplanned major (above the ankle) amputation of the target limb * Clinically-driven TVR (Target Vessel Revascularization) of the target limb
Time frame: One (1) year and three (3) years post-procedure
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Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Phoenix Heart Cardiovascular
Glendale, Arizona, United States
St. Luke's Medical Center
Phoenix, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Cedars-Sinai Heart Institute
Los Angeles, California, United States
Denver Heart
Denver, Colorado, United States
VA Eastern Colorado Healthcare System
Denver, Colorado, United States
Colorado Heart and Vascular, PC
Lakewood, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
...and 42 more locations