NCT01653600

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

Efficacy of Self-Expanding Nitinol S.M.A.R.T CONTROLTM Stent Versus Life Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease : Prospective, Multicenter, Randomized, Controlled Trial (SENS-FP-2 Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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 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. 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, 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.

Detailed description

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)

Conditions

• Peripheral Arterial Disease
• Atherosclerosis

Interventions

Type	Name	Description
DEVICE	S.M.A.R.T CONTROL Stent	Provisional stenting should be performed; the case that optimal ballooning response is not obtained (sub-optimal balloon response) should be enrolled. The procedure is usually done, as follows; After the guidewire is passed through the target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Recommended, minimal balloon dilation time is 120 seconds. The sub-optimal balloon response is defined as a residual pressure gradient of \>15 mmHg, residual stenosis of \>30%, and flow-limiting dissection.
DEVICE	LifeStent	same to SMART STENT

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-08-01
• Completion: 2015-08-01
• First posted: 2012-07-31
• Last updated: 2012-07-31

Locations

1 site across 1 country: South Korea