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CARDIAC CATH LAB - Mount Sinai Hospital

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Top Ten Key Clinical Trials:<br />

Study Study Sponsor PI Target Current<br />

Title Details Enrollment & Status/<br />

Study Sites Enrollment<br />

FREEDOM Trial Randomized trial comparing National Heart, S. Sharma 2,058 (global) Ongoing/60<br />

CABG vs. PCI in diabetic with Lung and subjects<br />

multi-vessel disease. To evaluate Blood Institute enrolled.<br />

whether PCI with DES is more (NHLBI) 28PCI/<br />

or less effective than the<br />

32CABG<br />

existing standard of care CABG.<br />

Multicenter, two-arm, open-label<br />

prospective randomized<br />

superiority trial with equal<br />

allocation of three yrs duration.<br />

IMPELLA A prospective,multi-center ABIOMED S. Sharma 650 (USA) Ongoing/<br />

PROTECT II Trial randomized controlled trial of<br />

18 subjects<br />

the IMPELLA® RECOVER® LP 2.5<br />

enrolled<br />

System versus intra-aortic balloon<br />

pump (IABP) in patients undergoing<br />

nonemergent high-risk PCI.<br />

SPIRIT Trial Prospective, two-arm, open-label, Abbott Vascular S. Sharma 500 Ongoing/<br />

multicenter registry using Xience (global)/ 5 subjects<br />

Prime EECSS and Xience Prime LL 10 <strong>Mount</strong> <strong>Sinai</strong> enrolled<br />

EECSS in de novo native coronary<br />

artery long lesions (length = 32 mm)<br />

with reference vessel diameters<br />

(2.25 mm to = 4.25 mm).<br />

ABCD-PCI Trial Early ambulation and discharge St. Jude Medical M. Kim 600/6 sites (USA) Ongoing/<br />

vs. overnight hospital stay for MSSM 222 subjects<br />

patients undergoing successful<br />

enrolled<br />

vascular closure after PCI.<br />

VWF Study To determine if BAV and AVR is MSSM J. Bander 100/Single Ongoing/<br />

effective at reversing the acquired Center MSSM 15 subjects<br />

Type 2- vWF syndrome seen in<br />

enrolled<br />

severe AS. Deficient vWF and<br />

Factor-VIII complex is responsible<br />

for bleeding.<br />

36 <strong>Mount</strong> <strong>Sinai</strong> <strong>Hospital</strong> Cardiac Cath Lab

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