Phase
Condition
Thrombosis
Coronary Artery Disease
Myocardial Ischemia
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
General Inclusion Criteria:
Patient must be female.
Patient must be at least 18 years of age.
Patient is able to verbally confirm understanding of risks, benefits and treatmentalternatives and she or her legally authorized representative provides writteninformed consent prior to any study related procedure, as approved by the appropriateMedical Ethics Committee of the respective clinical site.
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,silent ischemia, positive functional study or a reversible change in theelectrocardiogram (ECG) consistent with ischemia).
Patient must be an acceptable candidate for coronary artery bypass graft (CABG)surgery.
Patient must agree to undergo all protocol-required follow-up examinations.
Patients of childbearing potential must have had a negative pregnancy test within 7days before treatment, and must not be nursing at the time of treatment. Angiographic Inclusion Criteria:
Patients' artery morphology and disease is suitable to be optimally treated with amaximum of 4 planned study stents.
Target lesions must be de novo lesions (no prior stent implant, no priorbrachytherapy).
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
Target lesion greater than or equal to 28 mm in length by visual estimate.
Exclusion
General Exclusion Criteria:
Patient has other medical illness (e.g., cancer or congestive heart failure) or knownhistory of substance abuse (alcohol, cocaine, heroin etc.) that may causenon-compliance with the clinical investigation plan, confound the data interpretationor is associated with a limited life expectancy (i.e., less than one year).
Patient has a known hypersensitivity or contraindication to aspirin, either heparin orbivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot beadequately pre-medicated.
Participation in another device or drug study or has completed the follow-up phase ofanother study within the last 30 days.
Patient who is judged to have a lesion that prevents complete inflation of anangioplasty balloon.
Patient has had a previous stent implant, either Bare Metal Stent (BMS) or DrugEluting Stent (DES) within the target vessel(s)
Study Design
Study Description
Connect with a study center
Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, 1181
ArgentinaSite Not Available
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, 1428
ArgentinaSite Not Available
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Wien, 1090
AustriaSite Not Available
Heilig Hart Ziekenhuis Roeselare
Roeselare, 8800
BelgiumSite Not Available
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Sao Paulo, 04012-180
BrazilSite Not Available
Rigshospitalet
Copenhagen,
DenmarkSite Not Available
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
Massy, 91300
FranceSite Not Available
Kardiologische Klinik Herz- und Diabeteszentrum
Bad Oeynhausen, 32545
GermanySite Not Available
Segebergerkliniken
Bad Segeberg, 23795
GermanySite Not Available
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
Dresden, 01307
GermanySite Not Available
Semmelweis University, Department of Cardiovascular Surgery
Budapest,
HungarySite Not Available
Centro Cardiologico Monzino
Milan, 20138
ItalySite Not Available
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
Milano, 20149
ItalySite Not Available
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
Modena, 41100
ItalySite Not Available
Ospedale Cisanello
Pisa, 56127
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Latvian Center of Cardiology, P. Stradina University Hospital
Riga, 1002
LatviaSite Not Available
AMC
Amsterdam, 1105
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein, 3430
NetherlandsSite Not Available
Haukeland university hospital
Bergen, 5021
NorwaySite Not Available
Institute of Cardiology
Warsaw, 04-628
PolandSite Not Available
Hospital General de Alicante
Alicante, 3010
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
SpainSite Not Available
Inselspital Bern, Kardiologie
Bern, 3010
SwitzerlandSite Not Available
Cardiocentro Ticino
Lugano, 6900
SwitzerlandSite Not Available
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