Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease

Abstract

Based on the PTA performance efficacy rate of 33% derived from industry clinical trial data and the medical literature, and the requirement that the bare nitinol stent 12-month efficacy performance goal be set to equal twice this rate, the patency efficacy goal equals 66%. Additional information is provided on safety and other reporting standards and stent integrity evaluation for bare metal stents.

Outcomes for Clinical Studies Assessing Drug and Revascularization Therapies for Claudication and Critical Limb Ischemia in Peripheral Artery Disease

“…Although some groups support singlearm studies against optimal performance criteria, particularly for PAD device-based therapies, 62,63 they may provide an air of legitimacy that could bias providers and impede the completion of randomized trials assessing their efficacy compared with standard treatment.…”

“…77 This terminology extended into the percutaneous literature, with the additional definition of a >50% stenosis in an intervened artery as failed patency. 63 As described earlier, the legitimacy of this latter definition is questionable because it is an imperfect predictor of function, artery or graft occlusion, or need for reintervention.…”

Endovascular treatment of femoro-popliteal artery stenosis/obstruction using a repositionable self-expanding nitinol stent: a preliminary study

“…Moreover, bare nitinol stenting was shown to be associated with high rates of restenosis. These findings have led to the development of numerous new stents to increase graft patency survival [18,19]. Among them, the Supera helical interwoven stent stands out for its enhanced flexibility to resist against fracture when placed in the femoro-popliteal artery.…”

Drug-Eluting Stents Are the Default Strategy for Superficial Femoral Artery Intervention Now

“…21 Remarkably, after >40 years, PTA remains the standard of reference for all percutaneous technologies. [22][23][24][25][26][27][28][29][30][31] The appeal of endovascular therapy was obvious. Conscious sedation and local anesthesia completely sidestepped the complexity, risk, and expense of general anesthesia.…”

“…A generally accepted performance goal is that suggested by the VIVA Physicians Group, which includes a 1-year primary patency (PP) of 33%. 22 Acute and long-term limitations of PTA preclude its acceptance as a default treatment strategy for FP occlusive disease. These weaknesses have served as stimuli for the development of a broad selection of supplemental or alternative endovascular treatments.…”