Department of Surgery Clinical Trials

• Overview:  A prospective, observational post-market registry collecting  outcomes through a 10-year post procedure follow-up for subjects treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice. Collect mid- and long-term post-market clinical follow-up data for the EXCC or IBE devices us This registry collects data from different types of devices known as stent-grafts. Stent-grafts consist of a plastic material which is surrounded on the outside by a metal frame. This device acts like a hose where blood can flow through it, but also seals off diseased areas from blood flow. The shape of the stent-graft may be different depending on what part of the body requires treatment. The name of the devices being looked at are the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device (registry device) 
• Study Aims: The primary aim of this study is to collect mid- and long-term real-world data (RWD) on the performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) and the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE). 
• Eligibility: To be included, patients must be at least 18 years old, provide written informed consent, and be intended for treatment with an eligible registry device. 

Study/Sponsor Website: GORE® EXCLUDER® TAMBE

• Overview: The purpose of this protocol is to outline the scientific rationale, methodology, safety oversight, and operational procedures required to conduct the randomized controlled trial of the Nectero EAST System.  
• Study Aims: The aim of the stAAAble Trial is to determine whether the Nectero EAST® System can effectively reduce abdominal aortic aneurysm (AAA)–related clinical events—specifically death, rupture, or need for repair—in patients with small to mid‑sized AAAs. As stated in the protocol, the study also seeks to evaluate treatment‑related adverse events within 30 days and assess aneurysm growth over time compared with standard surveillance. 
• Eligibility: Eligible participants are adults aged 21 to 85 with an infrarenal, atherosclerotic, fusiform abdominal aortic aneurysm measuring 3.5–5.0 cm in men or 3.5–4.5 cm in women, confirmed by CT imaging. They must have an aortic neck at least 15 mm long and no more than 29 mm in diameter, and an overall aneurysm treatment length not exceeding 130 mm.
• Study/Sponsor Website: Nectero Therapeutics

• Overview: The purpose of this prospective, single-arm, multicenter post-market study is to collect real-world clinical outcomes data from subjects treated with the TAMBE Aortic Component in the United States. It specifically monitors the long-term safety and performance of the device for up to 10 years to fulfill regulatory post-approval requirements. 
• Study Aims: The primary aim is to confirm that the benefit-risk assessment of the TAMBE Device remains positive during real-world use following its FDA approval. Additionally, the study aims to ensure the adequacy of the associated TAMBE Device training program for healthcare providers. 
• Eligibility: To be eligible, subjects must be at least 18 years of age and provide signed informed consent personally or through a legal representative. Most importantly, they must be undergoing endovascular repair of an aortic disease involving the visceral vessels using the TAMBE Aortic Component.
• Study/Sponsor website:  GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)

• Overview: The purpose of this prospective, observational post-market registry is to collect real-world data on the long-term performance and characterization of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG). The study intends to demonstrate that thoracic endovascular aortic repair (TEVAR) remains a suitable treatment option in standard medical practice while addressing evolving regulatory demands for proactive device surveillance. 
• Study Aims: The primary aim is to collect mid- and long-term post-market clinical follow-up data through ten years to facilitate the continuing assessment of device performance and core functionality. Additionally, the registry aims to evaluate the impact of the treatment on patients’ quality of life and healthcare resource utilization through health economic and quality of life data analysis. 
• Eligibility: To be eligible for the registry, patients or their legally authorized representatives must provide written authorization and informed consent according to institutional and geographical requirements. Furthermore, patients must be at least 18 years of age and have been treated, or are intended to be treated, with an eligible CTAG registry device. 
• Study/Sponsor website:

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)