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Primary Study Publications

ACUITY

(principal investigator, CEC, angiographic core lab) 
Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM; ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355(21):2203-2216.

ADAPT-DES

(principal investigator, CEC, biostastistics)
Stone GW, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann F-J, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri E, Gurbel PA, Xu K, Parise H, Kirtane AJ, Brodie BR, Mehran R, Stuckey TD; ADAPT-DES Investigators. Platelet reactivity and clinical outcomes in patients receiving drug-eluting stents (ADAPT-DES): A prospective multicentre registry study. Lancet. 2013;382(9892):614-623.

CADILLAC

(principal investigator, angiographic core lab)
 
Stone GW, Grines CL, Cox DA, Garcia E, Tcheng JE, Griffin JJ, Guagliumi G, Stuckey T, Turco M, Carroll JD, Rutherford BD, Lansky AJ; Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) Investigators. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med. 2002;346:957-966.

COAPT

(principal investigator, CEC)
 
Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018;379(24):2307-2318.

EMERALD

(principal investigator, CEC, biostatistics, data management and analysis, angiographic core lab, ECG core lab)
 
Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: A randomized controlled trial. JAMA. 2005;293(9):1063-1072.

EXCEL

(principal investigator, data management and analysis, angiographic core lab, IVUS core lab)
 
Stone GW, Sabik JW, Serruys PW, Simonton CA, Généreux P, Puskas J, Kandzari DE, Morice M-C, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogáts G, Mansour S, Noiseux N, Sabaté M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Pagé P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein, EXCEL Trial Investigators. Everolimus-eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med. 2016;375:2223-2235.

FREEDOM

(Angiographic core lab)
 
Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012;367(25):2375-2384.

HORIZONS-AMI

(principal investigator, angiographic core lab, ECG core lab, IVUS core lab, CEC, data management and analysis)
 
Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Möckel M, Ochala A, Kellock A, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009;360(19):1946-1959.

ILUMIEN III: OPTIMIZE PCI

(principal investigator, data management and analysis, biostatistics, angiographic core lab, IVUS core lab)
Ali ZA, Maehara A, Généreux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016;388(10060):2618-2628.

INFUSE-AMI

(principal investigator, CEC, data management and analysis, angiographic core lab, cardiac MRI core lab, ECG core lab)
Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JE, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction. JAMA. 2012;307(17):1817-1826.

PHOENIX

(CHAMPION PHOENIX) (Angiographic core lab) 
Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimsky Petr, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Généreux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013;368(14):1303-1313.

PROSPECT

(principal investigator, CEC, angiographic core lab, IVUS core lab)

Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011;364(3):226-235.

RIVER-PCI

(principal investigator, CEC, angiographic core lab, data management and analysis, biostatistics, ECG core laboratory)
Weisz G, Généreux P, Iñiguez A, Zurakowski A, Shechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW; RIVER-PCI Investigators. Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016;387(10014):136-145.

SPIRIT III

(principal investigator and angiographic core lab)
 
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; the SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease. A randomized trial. JAMA. 2008;299(16):1903-1913.

SPIRIT IV

(principal investigator and angiographic core lab)

Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362(18):1663-1674.

TRYTON

(principal investigator, angiographic core lab)

Généreux P, Kumsars I, Lesiak M, Kini A, Fontos G, Slagboom T, Ungi I, Metzger DC, Wykrzykowska JJ, Stella PR, Bartorelli AL, Fearon WF, Lefèvre T, Feldman RL, LaSalle L, Francese DP, Onuma Y, Grundeken MJ, Garcia-Garcia HM, Laak LL, Cutlip DE, Kaplan AV, Serruys PW, Leon MB. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. J Am Coll Cardiol. 2015;65(6):533-543.

Heart Failure

Congestive heart failure (CHF) is a condition in which blood flow and pressure provided by the heart are not sufficient to meet the needs of the body.  CHF is most commonly caused by left, right, or biventricular dysfunction.  In many patients, heart failure is a result of coronary artery disease or pathologies of the heart valves.

While lifestyle modification and medications are critical to the treatment of CHF, surgery and device-based therapies are often indicated. For example, different types of pacemakers, implantable cardioverter defibrillator (ICDs) and cardiac resynchronization (CRT) devices, can be used to regulate rapid or slow heartbeats, or to help the heart beat stronger. Non-invasive as well as implantable pressure sensors are used to help tailor treatment. Clinical evaluation of left atrial pressure lowering devices is currently underway. Lastly, a mechanical pump, called a left ventricular assist device (LVAD), can be implanted to assist the heart in pumping blood.

CRF physicians have extensive experience in treating heart failure and performing basic and clinical studies to bring such therapies to patients. The CTC recently created a new Heart Failure, Hemodynamics and Circulatory Support department focused on CHF research initiatives.  We aim to support the regulatory and clinical trial needs of sponsors investigating new drug- and device-based treatments for heart failure at all stages of development.

Relevant CTC Service Areas for Heart Failure

• Trial Design
• Protocol Development
• Data Management
• Statistics And Programming
• Echocardiography Core Lab
• Hemodynamic Core Lab
• CT Core Lab
• CEC
• DSMB
• Medical Writing
• Extended Database Management and Analysis

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