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Vascular

 

BOLT Study

Have you ever been diagnosed with Deep Vein Thrombosis or DVT?  If you are feeling pain when you walk, one of your vessels may have significant narrowing or blockage. The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.

Please contact Yoselin Lugo or Tamar Capehart at 305-674-2071 for any questions or further information on how you can take part in The BOLT Study.

HERCULES Study

HERCULES is a multicenter clinical research study designed to evaluate endovascular repair strategies for infrarenal abdominal aortic aneurysms (AAA) in patients with challenging aortic neck anatomy. The study compares standard endovascular aneurysm repair (EVAR) using the Endurant™ II/IIs Stent Graft System with endosuture aneurysm repair (ESAR), which combines EVAR with the Heli-FX™ EndoAnchor System to enhance graft fixation and sealing. The goal of the HERCULES study is to assess safety, durability, and clinical outcomes to determine whether adjunctive endoanchors improve long-term repair success in complex AAA cases. This study’s principal investigator is Micheal T. Ayad, MD, Chief, Division of Vascular Surgery, Director, Vascular Institute, Co-Director, Aortic Center.

PERFORMANCE III Study

PERFORMANCE III is a prospective, multicenter clinical research study evaluating the Neuroguard IEP® System (an integrated carotid stent and embolic protection device developed by Contego Medical for direct transcarotid artery revascularization (TCAR) in patients with carotid artery stenosis. The Neuroguard IEP System combines a nitinol carotid stent, post-dilation balloon, and a 40-micron embolic filter on a single delivery platform and is used with a blood flow reversal embolic protection component to provide dual neuroprotection during the procedure. This study is designed to assess the safety and effectiveness of this device in reducing the rates of major adverse events such as stroke, myocardial infarction, or neurological death. This study’s principal investigator is Micheal T. Ayad, MD, Chief, Division of Vascular Surgery, Director, Vascular Institute, Co-Director, Aortic Center.

ROADSTER III Study

ROADSTER III is a multicenter clinical research study designed to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in a broad, real-world patient population with carotid artery disease. Building on earlier ROADSTER trials, the study assesses procedural outcomes such as stroke, death, and myocardial infarction, while examining the performance of contemporary TCAR techniques and devices across diverse clinical settings. The results aim to further define best practices and support evidence-based use of TCAR in routine clinical care. This study’s principal investigator is Micheal T. Ayad, MD, Chief, Division of Vascular Surgery, Director, Vascular Institute, Co-Director, Aortic Center.

STAND Study

STAND is a randomized, multicenter clinical research trial evaluating the MicroStent® Peripheral Vascular Stent System — an investigational nitinol stent designed by Micro Medical Solutions to treat infrapopliteal arterial disease below the knee in patients with peripheral arterial disease and critical limb‑threatening ischemia. In the study, patients are randomly assigned to receive either the MicroStent System in addition to standard percutaneous transluminal angioplasty (PTA) or PTA alone, with the goal of assessing the safety and effectiveness of the MicroStent in maintaining vessel patency, improving blood flow, and reducing the risk of limb loss compared to conventional treatment. This study’s principal investigator is Micheal T. Ayad, MD, Chief, Division of Vascular Surgery, Director, Vascular Institute, Co-Director, Aortic Center.

TOGETHER REGISTRY Study

TOGETHER REGISTRY is a prospective, observational, post-market clinical registry established to collect long-term real-world data on patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis or the GORE® EXCLUDER® Iliac Branch Endoprosthesis which are endovascular stent graft devices used in the repair of abdominal aortic aneurysms (AAA) as part of routine clinical care. The registry follows subjects for up to 10 years after their procedure to monitor device performance, capture patient outcomes, and provide insights into the safety, durability, and effectiveness of these devices in everyday practice outside of controlled clinical trials. This study’s principal investigator is Micheal T. Ayad, MD, Chief, Division of Vascular Surgery, Director, Vascular Institute, Co-Director, Aortic Center.

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