Efficacy of Self-Expanding Nitinol S.M.A.R.T-CONTROL Stent Versus Complete SE Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease (SENS-FP-1)

• The rate of binary restenosis [ Time Frame: one year ] [ Designated as safety issue: No ]
  binary restenosis is defined as the restenosis of at least 50 percent of the luminal diameter in the treated segment at 12 months after intervention, when determined by catheter angiography.
  
  

• stent fracture rate, clinical outcomes, angiographic outcomes, ankle-brachial index [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  1. Stent fracture rate
  2. Limb salvage free of above-the-ankle amputation
  3. Sustained clinical improvement rate
  4. Repeated target lesion revascularization rate
  5. Repeated target extremity revascularization rate
  6. Total re-occlusion rate
  7. Anigoraphic variables (Late loss, % restenosis)
  8. Ankle-brachial index
  9. The rate of major adverse cardiovascular events (MACE)
  10. The incidence of the stent geographic miss during stent deployment
  11. binary restenosis rate between clopidogrel and cilosatzol
  
  

Five randomized, controlled trials failed to demonstrate any benefit of a stainless-steel stent over angioplasty alone. The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions. Several studies reported stent fractures were associated with a higher risk of in-stent restenosis and reocclusion. In vitro, Stefan et al. reported the 7 different SFA stents showed differences in the incidence of high strain zones, which indicates a potential for stent fracture, as demonstrated by the mechanical fatigue tests. They claimed differences in stent design might play a major role in the appearance of stent strut fracture related to restenosis and reocclusion. Also, in retrospective study, Iida et al. reported there was significant difference in stent fracture between S.M.A.R.T. stent group and Luminexx stent group and primary patency was worse in those associated with stent fracture than in those without stent fractures. Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment. To the our knowledgement, however, randomized control trial for comparison of stent fracture and primary patency between different nitinol stents has not been done except one study; SMART versus Luminexx stent. Although there have been several retrospective or registry studies for atherosclerotic femoropopliteal disease in the EASE, the prospective randomized controlled trial for comparison of stent fracture and primary patency between different nitinol stents has not been done. Medtronic company have claimed Complete SE stent's crowns have been configured to minimize crown to crown interaction, increasing the stent's flexibility without compromising radial strength. On the other hand, 2011 ESC guideline recommended that dual antiplatelet therapy with aspirin and a thienopyridine for at least one month is recommended after infrainguinal bare-metal-stent implantation. Recent meta-analysis has shown that the efficacy of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However, still specific data regarding a variety of antiplatelet regimen are limited. Currently, selection of an antiplatelet regimen for the PAD patients should be individualized on the basis of tolerance and other clinical characteristics (i.e. bleeding) along with cost and guidance from regulatory agencies. Upto date, there is no the study for comparison between clopidogrel and cilostazol in the patient undergone stent implantation for femoropopliteal lesion. The purpose of our study is to examine and compare primary patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL versus Complete SE) and to compare binary restenosis rate between clopidogrel and cilostazol in femoropopliteal arterial lesion.