Comparison of BARD®LIFESTREAM™ covered balloon-expandable stent versus GORE® VIABAHN™ covered self-expandable stent in treatment of aortoiliac obstructive disease: study protocol for a prospective randomized controlled trial (NEONATAL trial)

BACKGROUND: Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with a higher patency rate than bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher a radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD to date. Therefore, this study aims to compare the efficacy and safety of CBE stent (BARD®LIFESTREAM™) and CSE stent (GORE® VIABAHN™) in AIOD. METHODS: This trial is a prospective, single-center, parallel, noninferiority, randomized controlled trial. A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or the CSE stent group. The primary end point of the study is the occurrence of target lesion revascularization (TLR) at 12 months after the intervention. DISCUSSION: To our knowledge, the ballooN sElf cOver steNt AorToiliAc occuLusive (NEONATAL) trial is the first RCT to compare CBE and CSE stent in AIOD patients. The main aim is to compare the TLR of the target lesion between CBE stent and CSE stent at 12 months post-procedure. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in the treatment of AIOD patients. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2100046734. Registered on 27 May 2021 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06332-7.