Efficacy of Self-Expanding Nitinol S.M.A.R.T CONTROL Stent Versus Life Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease (SENS-FP-2)

• 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 according to cilostazol use duration upto 12 month and 6 month
  
  

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 lesions. Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment. In vitro, Stefan et al. reported difference in stent design might play a major role in the appearance of stent strut fracture related to restenosis and reocclusion. Also, several retrospective or registry clinical studies reported stent fractures were associated with a higher risk of in-stent restenosis and reocclusion. In the literature, however, prospective, randomized, controlled, clinical trial for comparison of stent fracture and primary patency between different nitinol stents has never been performed except one study; SMART versus Luminexx stent named SuperSL trial (lesion length between 5-22 cm). Furthermore, in the Asian population, the study of this type have never been performed. LifeStent is similar to S.M.A.R.T. stent in the design consisted of the peak-to-valley connected with S-shaped bridge but is different in lesser bridge (4 bridge vs. 6 bridge), large cell size on stent ends, and larger cell size than S.M.A.R.T. 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 efficaty of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However, still specific data regarding a variety of antiplatelet regimen in implanted femoropopliteal lesion are limited. Upto date, in the literature, never has never been performed the clinical trial for optimal duration of cilostazol use in the patient undergone stent implantation for femoropopliteal lesion. Thus, 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 Lifestent) in femoropopliteal arterial lesion and to examine and compare the optimal duration of cilostazol use (6 month versus 12 month)