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Track record

Cardiology experience

Cardialysis has an unrivalled track record of more than 350 clinical trials (phase II and phase III, registry and post-marketing trials and investigator initiated studies) in cardiology. Cardialysis also has extensive experience in the design, regulatory handling, and conduct of trials with new types of devices and compounds in different therapeutic areas including but not limited to coronary artery disease, heart failure, electrophysiology, diabetes mellitus, atherosclerosis, hypertension, restenosis, stable angina pectoris and acute coronary syndromes. 

Cardialysis has been involved in numerous trials for submission to competent authorities in Europe, Northern America and Japan. These trials have been conducted with large multinational organizations but also with small start-up and biotech companies entering the field of cardiology. As a result, Cardialysis has established numerous partnerships with sponsors all over the world. 

Consequently, Cardialysis is an experienced and reliable partner for achieving your future clinical development goals on time and in a predefined fashion.

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Cardialysis landmark trials

In its 34 years of experience, Cardialysis has conducted a large number of landmark trials changing the landscape of cardiology practice as it is today. A summarized selection of these trials is given below:

  • ABSORB (Abbott, Bioresorbable scaffold)
    Serruys, Lancet 2009;373:897-910
    30 patients, 5 sites, Europe and New Zealand
    Services: design, Core Lab (QCA, IVUS, VH & OCT) & CEC adjudication
  • ABSORB Cohort B (Abbott, Bioresorbable scaffold)
    Ormiston, Lancet 2008; 371: 899–907
    Serruys, Lancet 2009; 373: 897–910
    101 patients, 10 sites in Europe and New Zealand
    Services: Core Lab (IVUS, VH, OCT, MSCT, Palpography & QCA)
  • APPROACH (GSK, rosiglitazone)
    Gerstein, Circulation 2010;121:1176-87
    672 patients, 92 sites, 19 countries in Europe, US, Asia and South Amercia
    Services: Core Lab (IVUS) 
  • BENESTENT (J&J, coronary stent)
    Serruys, NEJM 1994;331:489-95
    520 patients, 28 sites, 9 countries in Europe and South Amercia
    Services: design, data management, statistics, Core Lab: QCA, CEC adjudication, monitoring & coordination
  • COMPARE I and II (WESPH, drug eluting stent)
    Kedhi, Lancet. 2010 Jan 16;375(9710):201-9
    Smits, Lancet. 2013 23;381(9867):651-60
    Total : 4,500 patients in Europe
    Services: statistics, CEC adjudication & Core Lab (Syntax Score)
  • EUROPA (Servier, perindopril
)
    Fox, Lancet 2003;362:1-7
    
13,200 patients, 450 sites, 25 EU countries
    Services: design, data management, statistics & Core Lab (IVUS sub-study)
  • EXAMINATION (Abbott, bare metal stent & drug eluting stent)
    Sabate, JACC Cardiovasc Interv. 2014 Jan;7(1):55-63
    2,665 pts, 5 sites in Italy and Spain
    Services: statistics, CRF, data management, CEC adjudication, DSMB & monitoring
  • HELVETICA (Ciba Geigy, hirudin)
    Serruys, NEJM 1995;333:757-63
    
1,141 patients, 28 sites, 7 countries in Europe

    Services: design, Core Lab (QCA), CEC adjudication & statistics
  • IBIS-2 (GSK, darapladib)
    Serruys, Circulation 2008;118:1172-82
    330 patients, 25 sites, 10 countries in Europe
    Services: Core Lab (IVUS, VH & palpography) 
  • LEADERS (Biosensors, drug eluting stent)
    Windecker, Lancet 2008;372:1163–73
    1,707 patients, 10 sites in Europe
    Services: design, data management, Core Lab (QCA & Syntax Score), CEC adjudication & statistics
  • LIPS (Novartis, fluvastatine)
    Serruys, JAMA 2002;287:3215-22
    1,677 patients, 77 sites, 10 countries
    Services: design, data management & statistics
  • PROSPECT - Palpography sub study (Abbott, stent)
    Stone, N Engl J Med. 2011 20; 364(3):226-35
    350 patients, 40 sites in US and Europe
    Services: Core Lab (Palpography)
  • PURSUIT (Schering-Plough, eptifibatide)
    Harrington, NEJM 1998;339:436-43
    12,500 patients, 351 sites, 18 countries US, Europe and South America
    Services: data management & CEC adjudication
  • RAVEL (Cordis, drug eluting stent)
    Morice, NEJM 2002;346:1173-80
    238 patients, 19 sites, 7 countries in Europe and South-Amercia
    Services: design, data management, Core Lab (QCA), CEC adjudication & statistics
  • RESOLUTE (Medtronic, drug eluting stent)
    Serruys, N Engl J Med 2010; 363:136-462
    1,300 patients, 79 sites in Europe
    Services: protocol, statistics, data management, CEC adjudication & Core Lab (ECG & QCA)
  • SOFA (WCSF, fish oil)
    Brouwer, JAMA 2006;295:2613-19
    500 patients, 25 sites in Europe
    Services: data management, monitoring & Core Lab (ICD & ECG)

  • SYNTAX (Boston Scientific, stent & CABG)
    Serruys, NEJM 2009;360:961-72
    3,075 patients, 86 sites US and Europe
    Services: design, Core Lab (QCA & Syntax Score), CEC adjudication & monitoring
  • TWENTE I and II (Dutch Peers, drug eluting stent)
    Von Birgelen, Lancet. 2014 1; 383(9915):413-23
    Von Birgelen, J Am Coll Cardiol. 2012 10; 59(15):1350-61
    3,200 patients, 1,000 sites global
    Services: CEC adjudication