Atherosclerosis Clinical Trial
Official title:
Phase 4 Study of Efficacy of Balloon-Expandable Cobalt Chromium SCUBA Stent Versus Self-Expandable Stent COMPLETE-SE Nitinol Stenting for the Atherosclerotic ILIAC Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial
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.
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)
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