Clincal Trials:
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Aortic Aneurysm, Dissection and Trauma Treatment
- The (IRAD) International Registry for Acute Aortic Dissection - PI: Beck, Adam W
- Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta - PI: Beck, Adam W
- Zenith® p-Branch™ Pivotal Study - PI: Beck, Adam W
- Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms - PI: Beck, Adam W
- A Multicenter, Open Label, Prospective, Non-Randomized Study of the INCRAFT™ Stent Graft System In Subjects with Abdominal Aortic Aneurysms. Protocol No.P11-4601 - PI: Passman, Marc A.
- Aortic Trauma Foundation Prospective Blunt Thoracic Aortic Injury Registry - PI: Pearce, Benjamin Jay
- Assessment of the Gore® Excluder® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms - PI: Pearce, Benjamin Jay
- A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft with Navitel Delivery System for Patients with Infrarenal Abdominal Aortic Aneurysms - PI: Pearce, Benjamin Jay
- "GREAT" Global Registry for Endovascular Aortic Treatment Outcomes Evaluation - PI: Pearce, Benjamin Jay
- Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms - PI: Pearce, Benjamin Jay
- A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers - PI: Pearce, Benjamin Jay
- DISSECT-N a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections. – PI: Beck, Adam W.
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Carotid Stenosis
Carotid Revascularization and medical management for Asymptomatic Carotid Stenosis Trial (CREST-2) Sub-I: Beck, Adam W; Passman, Marc A
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Investigational Devices
Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal and Thoracoabdominal Aortic Pathologies Using the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft and Surgeon-Modified Endografts (Short Title: CMD and Zenith t-Branch) - PI: Beck, Adam W
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Investigator-Initiated Pilot Studies
Upcoming pilot study of the novel technology of 2-Dimensional Perfusion Software and evaluating the technical feasibility and benefit of 2D-perfusion angiography in determining the success of peripheral vascular interventions for patients with chronic limb-threatening ischemia. – PI: McFarland, Graeme
Development of an offloading device for the lower extremity to better decrease the pressure on the foot and promote healing in patients with diabetic foot ulcers PI: Unger, Kenneth -
Peripheral Arterial Disease
- An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients with Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures - PI: Passman, Marc A.
- Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (Best) - PI: Passman, Marc A.
- Peripheral Arterial Disease Screening Among Diabetes Mellitus (PADS-DM) - Phase 2 Long Term Follow-Up - PI: Pearce, Benjamin Jay
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Renal Function and Hypertension in Vascular Surgery
- Neo Legacy (Rheos®) Humanitarian Use Device (HUD/HDE H130007) - PI: Passman, Marc A.
- CALM-2 - Controlling and Lowering Blood Pressure with the MobiusHD® - PI: Passman, Marc A.
- Renal Injury After Vascular Surgery - PI: Beck, Adam W
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Supervised Exercise Therapy
- SVS Pilot of Supervised Exercise Therapy - PI: McFarland, Graeme
- Physical Activity Daily- An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD) – PI: Jackson, Elizabeth
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Venous Disease
- A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL™ PRIME for the Treatment of Chronic Venous Leg Ulcers - PI: Passman, Marc A.
- Evaluation of the Zilver Vena Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (VIVO Clinical Study) - PI: Passman, Marc A.
- Inferior Vena Cava Filter Placement and Retrieval and Patient Compliance - PI: Passman, Marc A.
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Veteran Aneurysm Care
Our Vascular Surgery team at the Birmingham VA seeks to better understand Veteran perspectives in aneurysm care, having completed enrollment as a site in the Preferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA trial), a national VA multisite clinical survey trial of Veteran preferences for open vs endovascular abdominal aortic aneurysm repairs in patients at or near threshold for repair where there was clinical equipoise between the two treatment options. – Site PI: Spangler, Emily
Assessment of Abdominal Aortic Aneurysm Repair Imaging Surveillance Practices in Veterans; NIH NCATS: 1KL2 TR003097-01- PI: Spangler, Emily L Imaging surveillance is required life-long following certain types of vascular repairs, however, the rates for guideline-recommended imaging following aortic aneurysm repairs have been poor in studied populations. The Veterans Administration (VA) as the largest integrated health care system in the US whose national clinical capture makes it an optimal venue for accurately characterizing imaging rates and identifying facilitators and barriers to aneurysm imaging surveillance. Ongoing work seeks to establish targets for improving aneurysm imaging surveillance through both large-scale clinical database analysis and qualitative assessment of patients about their aneurysm care.
Basic Science and Translational Studies:
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Ren Laboratory
The research in the Ren Laboratory seeks to determine critical molecular and transcriptional signaling pathways in the transdifferentiation of vascular endothelial cells, vascular niche in stem cell maitenance and self-renewal, angiogenesis (the formation of new blood vessels from preexisting blood vessels), and arteriogenesis (de novo formation of small arteries), and to develop molecular strategies for stimulating or inhibiting the growth of new blood vessels. The current research focuses on how extracellular signaling couples epigenetic and transcriptional regulation of endothelial cell differentiation and functional angiogenesis to control the development of cardiac, peripheral and cerebral vessels in heart and vascular disease, cancer, obesity, neurological disorders and the cardiovascular complications of diabetes. Elucidating the cellular and molecular mechanisms of endothelial cell differentiation and functional angiogenesis using their established state-of-the-art approaches and innovative transgenic animals as well as human specimens will aid in the understanding of the pathobiology of these conditions and in the discovery of innovative and effective therapeutic strategies to promote public health of human being.
Currrent studies: Epigenetic and Transcriptional Regulation of Angiogenic Regulator CD36 and Transformation of Capillaries into Small Arteries - PI: Ren, Bin
Vascular Outcomes Research:
The UAB Division of Vascular Surgery and Endovascular Therapy maintains an active portfolio of vascular outcomes research and quality improvement and clinical protocol research.
Our team of trainees, staff and faculty gather for regular research meetings (the 1st and 3rd Fridays of each month) to collaborate, give feedback and practice presentation skills related to vascular surgery research; please email espangler@uabmc.edu for further details if interested in attending.
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Enhanced Recovery Pathways and Clinical Protocols
Standardized care in surgical processes has been shown to improve outcomes and reduce disparities. Our division has taken active role to develop, and implement evidence-based strategies and best practices to treat a variety of complex conditions including prevention of spinal cord ischemia in aortic repairs, enhancing recovery around lower extremity bypass and aortic surgery, and repair of vessels associated with cardiac support devices. Please see sites below for further details.
- Spinal Cord Ischemia treatment protocol
- Lower Extremity Bypass Enhanced Recovery Protocol (ERP), Implementation
Clinical Database Research
Current and prior faculty and trainee projects utilizing the Society for Vascular Surgery Vascular Quality Initiative (VQI), Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Coordinated Registry Network and International Consortium of Vascular Registries (ICVR) databases include projects in the domains below, with work by trainees in bold:
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Carotid
Stewart LM, Spangler EL, Sutzko DC, et al. Carotid Endarterectomy with Concomitant Distal Endovascular Intervention is Associated with Increased Rates of Stroke and Death [published online ahead of print, 2020 Jul 21]. J Vasc Surg. 2020;S0741-5214(20)31710-9.
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Peripheral Vascular Disease
- Leithead C, Novak Z, Spangler E, Passman MA, Witcher A, Patterson MA, Beck AW, Pearce BJ. Importance of postprocedural Wound, Ischemia, and foot Infection (WIfI) restaging in predicting limb salvage, JVS 2018; 67(2):498-505.
- Axley JC, McFarland GE, Novak Z, Scali ST, Patterson MA, Pearce BJ, Spangler EL, Passman MA, Beck AW, Factors Associated with Amputation after Peripheral Vascular Intervention for Intermittent Claudication. Ann Vasc Surg 2020; 62:133-141
- Stewart L, Pearce BJ, Beck AW, Spangler EL. Examination of race and infrainguinal bypass conduit use in the Society for Vascular Surgery Vascular Quality Initiative [published online ahead of print, 2020 May 25]. Vascular. 2020
- Mullins, CH et al “Prevalence and Outcomes of Endovascular Infrapopliteal Interventions for Intermittent Claudication” accepted for publication, Annals of Vascular Surgery 2020
- Stewart LM et al “Thoracofemoral Bypass Outcomes in the Vascular Quality Initiative” under review
- Spangler EL et al “Common Femoral Artery Stenting in the VQI” **VISION CRN project
- Aucoin V et al “Examination of Postoperative perfusion outcomes and limb salvage in peroneal bypass”
- Spangler EL et al “Outcomes of pedal access techniques”
- Spangler EL et al “Examination of Racial Disparities in Length of Stay in Lower Extremity Bypass Surgery”
- Bolaje B et al “Examination of the Impact of Obesity on Lower Extremity Bypass Readmissions and Financial Implications of Readmissions”
- Sutzko D et al “Disparities in Vascular Care for African American End-Stage Renal Disease (ESRD) Patients with Chronic Limb-Threatening Ischemia (CLTI)”
- Sutzko D et al “Use of Intravascular Ultrasound (IVUs) During Peripheral Vascular Intervention and its Impact on Stent Use”
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Medical Management and Perioperative Care
- Parmar GM, Novak Z, Spangler E, Patterson M, Passman MA, Beck AW, Pearce BJ. Statin use improves limb salvage after intervention for peripheral arterial disease. JVS 2019; 70(2):539-546
- Moore, JL McFarland GE, Novak, Z, Patterson, MA, Haverstock B, Passman MA, Spangler, EL, Pearce, BJ, Beck AW, Effects of statin and antiplatelet therapy noncompliance and intolerance on patient outcomes following vascular surgery. JVS 2020, 71(4):1358-1369
- Stewart LM et al "The Association Between Preoperative Length of Stay and Surgical Site Infection After Lower Extremity Bypass for Chronic Limb-Threatening Ischemia," accepted for publication, JVS 2020
- Axley, J, et al “Describing Clinically Significant Arrhythmias in Postoperative Vascular Surgery Patients”
- Boudreau H, et al “Effects of Statin and Antiplatelet Therapy on Mortality Rates in Abdominal Aortic Aneurysm Patients”
- Rajaei M, McFarland G et al “Describing the usage of different antiplatelet/ anticoagulation regimens in patients with peripheral arterial disease”
- Beck AW et al “Use of direct oral anticoagulants following lower extremity revascularization and the associated bleeding and thrombotic complications”
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Aortic Surgery
- Beck AW, Sedrakyan A, Mao J, et al. Variations in Abdominal Aortic Aneurysm Care: A Report From the International Consortium of Vascular Registries. Circulation. 2016;134(24):1948-1958 **ICVR project
- Torrent DJ, McFarland GE, Wang G, Malas M, Pearce BJ, Aucoin V, Neal D, Spangler EL, Novak Z, Scali ST, Beck AWl. Timing of TEVAR for Uncomplicated Acute Type B Aortic Dissection and the Association with Complications [published online ahead of print, 2020 Jul 2]. J Vasc Surg. 2020;S0741-5214(20)31464-6.
- Aucoin V, et al, “Trends in Use of Cerebrospinal Drains and Outcomes Related to Spinal Cord Ischemia after TEVAR and complex EVAR in the Vascular Quality Initiative”
- Aucoin VJ, Eagleton MJ, Farber MA, Oderich GS, Schanzer A, Timaran CH, Schneider DB, Sweet MP, Beck AW, Spinal Cord Protection Practices Utilized During Endovascular Repair of Complex Aortic Aneurysms Among the United States Aortic Research Consortium Journal of Vascular Surgery (2020), doi: https://doi.org/10.1016/j.jvs.2020.07.107.
- Heslin R, et al “Endovascular Repair of Thoracoabdominal Aneurysms: The Impact of Extent on Mortality”
- Blakeslee-Carter, J “Examining the Occurrence, Outcomes, and Clinical Relevance of Type 3 Endoleaks after Endovascular Aortic Aneurysm Repair” **VISION CRN project
- Novak Z, et al “Evaluation of the risk of renal damage after aortic procedures”
- Beck AW, et al “Outcomes of thoracoabdominal aortic aneurysm treatment based on extent of aortic coverage within physician-sponsored Investigational Device Exemption”
- Beck AW, et al “International Variation in Endovascular Treatment of Thoracic Aortic Pathology”
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Venous Disease
Weber, J et al “Comparison of complication rates of IVC filters based on anticoagulant and indication”
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Veteran Outcomes
Spangler EL “Assessment of Abdominal Aortic Aneurysm Repair Imaging Surveillance Practices in Veterans; NIH NCATS: 1KL2 TR003097-01”
Imaging surveillance is required life-long following certain types of vascular repairs, however, the rates for guideline-recommended imaging following aortic aneurysm repairs have been poor in studied populations. The Veterans Administration (VA) as the largest integrated health care system in the US whose national clinical capture makes it an optimal venue for accurately characterizing imaging rates and identifying facilitators and barriers to aneurysm imaging surveillance. Ongoing work seeks to establish targets for improving aneurysm imaging surveillance through both large-scale clinical database analysis and qualitative assessment of patients about their aneurysm care.
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Tertiary Medical Center Database Investigations
Apart from research in surgical quality databases, we also utilize review of our electronic medical record from our tertiary medical center to evaluate unique populations in vascular surgery. Samples of ongoing investigations include:
- Menon A, McFarland GE et al “Associations of mental health conditions with processes and outcomes of aortic dissection care”
- Allan JM, Spangler, EL et al “Changes in aortoiliac diameters over time in patients with pelvic malignancies”
- Lagrone RB, Pearce JB et al “Iatrogenic Vascular Injury Cases”
- Shao C, Blakeslee-Carter J, McFarland GE et al “Surgical Management of Vascular Complications After Cannulation
- Beck AW et al “Evaluation of the Temporal Incidence of Post-Operative Myocardial Infarction in Patients Undergoing Vascular Surgery Interventions”
- Patterson MA et al “Vascular Surgery Data Research Repository”
- Pearce BJ et al “Long Term Evaluation of Patients Aortic Disease”
- Pearce BJ et al “Outcome of Patients with Peripheral Arterial Disease”
- Pearce BJ et al “Short Term and Long Term Evaluation of Patients with Carotid Disease”
- Pearce BJ et al “Renal Artery Aneurysm and Other Arterial Pathology”
- Pearce BJ et al “Assessment of the Hospitalized Population requiring Evaluation by Vascular Surgery Service”