88
CLINICAL TRIALS AND RESEARCH
• Kandzari DE , Townsend RR , Bakris G , Basile J , Bloch MJ , Cohen DL , East C , Ferdinand KC , Fisher N , et . al . Renal denervation in hypertension patients : Proceedings from an expert consensus roundtable cosponsored by SCAI and NKF . SCAI Think Tank Proceeding . 2021 August 3 .
• Schwartz GG , Szarek M , Bittner VA , Steg GP , et . al . Lipoprotein ( a ) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol . ODYSSEY Outcomes Committees and Investigators . Journal American College of Cardiology . 2021 August 3 ; 78 ( 5 ): 421-433 .
• Mahfoud F , Kandzari DE , Kario K , East C , Böhm , et al . Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs : Results from the randomised , sham-controlled SPYRAL HTN-ON MED trial . The Lancet . ( April , 2022 )
A notable international presentation in fiscal year 2022 included Women in PARADISE . Sex differences in clinical characteristics and outcomes after myocardial infarction : insights from PARADISE-MI , featured at the European Society of Cardiology in June , 2022 . Presenters included SCRC ’ s Dr . East along with Maja Cikes , Brian Claggett , Christopher B . Granger , Ya-Ling Han , Karola S . Jering , Eldrin F . Lewis , John J . V . McMurray , Roxana Mehran , Freny V . Mody , Marc A . Pfeffer , Scott D . Solomon , Mariya Tokmakova , and Xiaowen Wang .
Key multi-year studies SCRC has continued to lead include :
• SPYRAL ON MED - Global clinical study of renal denervation with the Symplicity Spyral multielectrode renal denervation system in patients with uncontrolled hypertension on standard medical therapy . Principal investigators : James W . Choi , MD ; Cara East , MD .
• SPYRAL OFF MED - Global clinical study of renal denervation with the Symplicity Spyral multielectrode renal denervation system in patients with uncontrolled hypertension in the absence of antihypertensive medications : SPYRAL Study . The Dallas site ranked # 1 in enrollment and ranked # 3 for randomization . Principal investigators : James W . Choi , MD ; Cara East , MD .
• SPYRAL DYSTAL - Global clinical study of renal denervation in the distal main and first order branch renal arteries using the Symplicity Spyral multi-electrode renal denervation system . Principal investigators : James W . Choi , MD ; Cara East , MD .
Additional SCRC studies in fiscal year 2022 include :
AMGEN Lpa - A multi-center , cross-sectional study to characterize the distribution of lipoprotein ( a ) levels among patients with documented history of atherosclerotic cardiovascular disease ( ASCVD ). Principal investigator : Cara East , MD .
CLEAR - A randomized , double-blind , placebocontrolled study to assess the effects of bempedoic acid ( ETC-1002 ) on the occurrence of major cardiovascular events in patients with , or at high risk for , cardiovascular disease who are statin intolerant . Principal investigator : Cara East , MD .
CONNECT-AV - A prospective , multi-center clinical study of the BD WavelinQ EndoAVF System for the creation of arteriovnous AV Fistula in patients requiring dialysis ( CONNECT-AV ). Principal investigator : Stephen Hohmann , MD .
DELIVER - A prospective , single-arm , multi-center study of the metavention integrated radio frequency denervation system to improve glycemic control in type 2 diabetic subjects . Principal investigator : James Choi , MD .
ENTRIGUE - A phase 2 , randomized , double-blind , placebo-controlled study to explore the efficacy and safety of BIO89-100 in subjects with severe hypertriglyceridemia . Principal investigator : Cara East , MD .
FLOW - Study focused on the effect of semaglutide vs placebo in Type 2 diabetics with chronic kidney disease . Principal investigator : Cara East , MD .
GENETICURE - Association between a multigene panel and renal denervation effectiveness in patients with hypertension ( GxRDxHTN ). An observational study designed to assess whether renal denervation ( RDN ) effectiveness using the Symplicity Spyral™ multi-electrode renal denervation system is associated with ranked genomic scoring from the Geneticure multi-gene algorithm for renal denervation . The study will assess if subjects who have a high genetic score , based on the hypothesized importance of the organ systems involved , will have differential responsiveness to RDN in a descending order . Principal investigator : Cara East , MD .
HERITAGE - A multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein ( a ) levels among patients with established cardiovascular disease . Principal investigator : Cara East , MD .