RECONSTRUCT study protocol for real-world outcomes of covered endovascular reconstruction of the aortic bifurcation using the GORE VIABAHN VBX balloon-expandable endoprosthesis to treat aortoiliac occlusive disease

<h2>Abstract</h2><h3>Objective</h3> Aortoiliac occlusive disease (AIOD) is a common manifestation of peripheral artery disease (PAD), and contributes substantially to global morbidity and mortality. Although open surgical repair provides durable outcomes, its risks have led to a shift toward endovascular-first strategies. The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique has emerged as a promising option for complex AIOD. The objective of this manuscript is to describe the methodology of the RECONTSRUCT study, designed to evaluate the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in the CERAB procedure for AIOD. <h3>Methods</h3> The RECONSTRUCT study is a multicenter, single-arm, retrospective study enrolling at least 158 patients across 35 sites in the United States and Europe. Data collection includes demographics, medical history, procedural details, device characteristics, and clinical follow-up from electronic health records. The primary effectiveness endpoint is 1-year primary patency, defined as uninterrupted blood flow (<50% binary restenosis) through the CERAB devices without target lesion revascularization (TLR). The primary safety endpoint is 30-day morbidity, defined as any major adverse cardiovascular event or procedure related reintervention. Secondary endpoints include technical success, 30-day mortality, freedom from device fracture, primary assisted and secondary patency, freedom from TLR and clinically-driven TLR, and overall survival. <h3>Conclusion</h3> The study will provide real-world, multicenter evidence on VBX stent graft use in CERAB for AIOD. Standardized data collection with independent review and adjudication will enhance data reliability, and findings may address an important evidence gap in managing complex aortoiliac disease.