The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.

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defect is an alternative method, especially when the atrial septum is thickened and resistant to pull-through BAS. Such conditions can be anticipated in infants aged >4-6 weeks or in those with left-sided obstructive lesions such as hypoplastic left heart syndrome (HLHS). 2-5 In addition, all the catheters that could be used for pull-through BAS in Japan required a sheath of 6Fr or larger until recently, which may increase access-related complications in small infants. Therefore, in Japan, static BAS has also been used as an alternative to pull-through BAS to reduce vascular injury in patients with low body weight.Although static BAS cannot be replaced by surgical Balloon atrial septostomy (BAS) is an essential catheterization procedure for some congenital heart lesions that require interatrial communication, such as to increase cardiac output in right-sided obstructive lesions, to enhance mixing in patients with transposition of the great arteries (TGA), and to relieve left atrial hypertension in left-sided obstructive lesions.Pull-through BAS, in which the inflated balloon catheter is forcefully pulled through the atrial septum to tear open the atrial septum, is the conventional and standard BAS method. 1 Static BAS (or static balloon atrial septal dilation) using a dilation balloon to enlarge the atrial septal

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