Clinical Studies for Vascular and Endovascular Surgery

Title: Assessment of Long Term, Endovascular AAA Intervention using the GORE EXCLUDER Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis; Gore Together Aortic Registry Protocol
Brief Title: GORE EXCLUDER Conformable
Brief Summary:
For info regarding 2024P000457 please contact Marc Schermerhorn at 617-632-9971 or mscherme@bidmc.harvard.edu
 
Title: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion AAA - SHAPE Pivotal Trial CRD 1029 November 7, 2023, Version 12
Brief Title: AAASHAPE MEMORY
Brief Summary: To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
For info regarding 2024P000223 please contact Su Huang at 617-632-7448 or shuang9@bidmc.harvard.edu
 
Title: stAAAble Trial: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
Brief Title: STAAABLE TRIAL
Brief Summary: The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
For info regarding 2024P000038 please contact Su Huang at 617-632-7448 or shuang9@bidmc.harvard.edu
 
Title: Zenith Fenestrated+ Endovascular Graft Clinical Study Global Clinical Number 17-07
Brief Title: FEN PLUS
Brief Summary: The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
For info regarding 2023P000909 please contact Su Huang at 617-632-7448 or shuang9@bidmc.harvard.edu
 
Title: The GORE VBX FORWARD Clinical Study: A Comparison of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX) to Bare Mental Stenting for Patients with Complex Iliac Occlusive Disease
Brief Title: GORE VBX
Brief Summary: The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
For info regarding 2023P000760 please contact Su Huang at 617-632-7448 or shuang9@bidmc.harvard.edu
 
Title: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients with Chronic Limb Threatening Ischemia (CLTI
Brief Title: SELUTION BTK
Brief Summary: This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
For info regarding 2023P000457 please contact Su Huang at 617-632-7448 or shuang9@bidmc.harvard.edu
 
Title: EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)
Brief Title: ADVANCE Trial
Brief Summary: The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
For info regarding 2022P000523 please contact Su Huang at 617-632-7448 or shuang9@bidmc.harvard.edu