Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease
Condition: Peripheral Artery Disease; Atherosclerosis
MeSH terms: Atherosclerosis; Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The purpose of the investigators study is to examine and compare primary patency between
      balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus
      COMPLETE-SE) in atherosclerotic iliac artery lesion.
    

Detailed description: 
      Obstructive atherosclerotic disease of the distal aorta and iliac arteries is preferentially
      treated with endovascular techniques, and an endovascular-first strategy can be recommended
      for all TransAtlantic Inter-Society Consensus (TASC) A-C lesions. Low morbidity and mortality
      as well as a >90% technical success rate justify the endovascular-first approach. Currently,
      In an attempt to improve outcomes, stent use has increased, and a number of studies favor
      iliac stenting over simple Percutaneous Transluminal Angioplasty (PTA). A meta-analysis
      comparing iliac stenting to Percutaneous Transluminal Angioplasty (PTA) found that stenting
      had higher rates of technical success and was associated with a 39% reduction in the risk of
      long-term loss of patency.

      However, randomized control trial for comparison of primary patency between balloon
      expandable stent and self expandable stent has not been done, although there were some trials
      in that primary patency was compared among balloon expandable stents or among self expandable
      stents.

      Currently, The choice of balloon versus self expandable stents is determined mainly by
      operator preference. The main advantages of balloon expandable stents are the higher radial
      stiffness and the more accurate placement, which is especially important in bifurcation
      lesions. In the external iliac artery, a primary stenting strategy using self-expandable
      stents compared with provisional stenting is preferred mainly due to a lower risk of
      dissection and elastic recoil.

      Thus, the purpose of our study is to examine and compare primary patency between balloon
      expandable stent and self expandable stent(SCUBA versus COMPLETE SE stent)
    

Intervention name(s): Balloon expandable stent; Self expandable stent
Intervention type(s): Device; Device
Intervention description(s): provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection; provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection
Other intervention name(s): SCUBA stent; COMPLETE SE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral artery disease; atherosclerosis; stent