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Research Laboratory

CLINICAL OUTCOMES RESEARCH

1. A Phase II Single-arm, Prospective Study of the Safety and Efficacy of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms in Patients who are not Candidates for Repair with Commercially Available Bifurcated Endovascular Prostheses.
The primary study objective is to determine the safety and efficacy of the UniFit™ Aorto-uni-iliac (AUI)Endoluminal Stent Graft (the “study device”) for the repair of abdominal aortic aneurysms (AAAs) in patients who are not candidates for repair with commercially available bifurcated endovascular prostheses and are at high risk for conventional surgical repair.
2. Zenith TX2®TAA Endovascular Graft Post Market Approval Study (08-005-02)
The goal of this study is to evaluate the long term (5year) safety and effectiveness of the Zenith TX2®TAA Endovascular Graft for the treatment of descending thoracic aortic aneurysms.
3. Evaluation of Cilostazol in Combination with L-Carnitine in Subjects with Intermittent Claudication
To determine the effect of cilostazol combined with L-Carnitine on change in peak walking time compared to cilostazol alone. This is a prospective, randomized, placebo controlled comparison of cilostazol vs. cilostazol in combination with L-Carnitine for treatment of intermittent claudication.
4. Effect of hypercholesterolemia-induced oxidative stress on hematopoietic stem cell quiescence and lineage differentiation.
5. Does oxidative stress cause premature aging of hematopoietic stem cells and altered T cell development resulting in an increased of colon cancer induced by carcinogen.
6. Risk Stratification in Critical Limb Ischemia: Derivation and Validation of a Simplified Model to Predict Amputation-Free Survival Using Multi-Center Surgical Outcomes Data
Two datasets of critical limb ischemia patients who underwent surgical bypass are being analyzed in order to create a prognostic instrument for determining amputation-free survival (AFS): the PREVENT III randomized trial (n=1404) and a multicenter registry (n=716) from 3 distinct vascular centers (2 academic, 1 community-based). The PREVENT III cohort was randomly assigned to a derivation set (n=953) and to a validation set (n=451). Predictors of AFS identified on univariate screen were included in a multivariate stepwise selection Cox model. The resulting 5 significant predictors were assigned an integer score to stratify patients into 3 distinct risk groups. The prediction rule was internally validated in the PREVENT III validation set and is being externally validated in the multicenter cohort. Future studies will attempt to assess this prediction rule in a cohort of patients undergoing endovascular revascularization.
7. . Vascular Surgery Training Trends From 2001-2007: A Substantial Total Volume Increase Driven by Escalating Endovascular Volume and Stable Open Volume
Vascular surgery trainees are required to log both open and endovascular procedures with the Accreditation Council for Graduate Medical Education (ACGME). We analyzed the ACGME database (2001-2006), which records all cases (by CPT code) performed by graduating vascular fellows. Case volume was evaluated according to the mean number of cases performed per graduating fellow.
8. Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms in the United States (2001-2005): Hospital Volume of Elective Endovascular AAA Repair Independently Predicts Improved Mortality When Dealing With Ruptures
Endovascular aortic repair (EVAR) has gained wide acceptance for the elective treatment of abdominal aortic aneurysm (AAA). Increasingly, this modality has been applied to the management of patients with ruptured abdominal aortic aneurysms (RAAA). The purpose of this study, based on a large representative national database, was to evaluate to what extent elective hospital AAA volumes for both open and endovascular repair affect outcomes for ruptured aneurysms in the United States.
9. An Analysis of 4001 Carotid Artery Stenting Procedures According to Operator Specialty: Periprocedural Stroke and Mortality Rates No Different Between Vascular Surgeons and Interventionalists
Carotid artery stenting is currently being performed by several different specialty groups. The purpose of this study is to utilize carotid artery stenting discharge data from New York and Florida that allow for the determination of operator specialty. Patient characteristics and outcome data are both being analyzed and compared according to specialty type.
10. . Carotid artery stenting has increased rates of post-procedure stroke, death, and resource utilization than does carotid endarterectomy in the United States.
United States data on more than 400,000 carotid endarterectomy and carotid stent procedures has been analyzed demonstrating that, on a national level, outcomes with carotid angioplasty and stenting are inferior to carotid endarterectomy.