Phase
Condition
Coronary Artery Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visualestimation or equivocal disease by angiography.
- Age ≥18 years.
- Ability to give preliminary oral consent witnessed by an independent physician or signwritten informed consent prior to any study-specific procedures.
Exclusion
Exclusion Criteria:
- Significant distal lesions (>50% angiographic DS on visual estimation within the leftanterior descending artery [LAD] or left circumflex artery [LCX], except for ostium ofLAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch])
- Ostial LM disease.
- Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
- LM In-stent restenosis.
- Previous coronary stenting of the left coronary system.
- Chronic total occlusion.
- Previous coronary artery bypass graft.
- Previous MI related to the left coronary artery.
- Occurrence of ventricularization or hypotension during engagement of the LM ostiallesion.
- The presence of hemodynamic instability.
- Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis).
- Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
- Life expectancy less than 1 year.
- Contraindication or known allergy against protocol-required medications includingheparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
- Body mass index >35kg/m2.
- Complex congenital heart disease other than anomalous coronary origins alone.
- Ventricular septal defect.
Study Design
Connect with a study center
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
FranceActive - Recruiting
Institute Mutualiste Montsouris
Paris, 75014
FranceActive - Recruiting
Centre Cardiologique du Nord
Saint-Denis, 75014
FranceActive - Recruiting
Universitätsklinikum Giessen Justus-Liebig Universität
Gießen, Hesse 35392
GermanyActive - Recruiting
Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
Erlangen, 91054
GermanyActive - Recruiting
Ageo Central General Hospital
Ageo, 362-8588
JapanActive - Recruiting
Gifu heart center
Gifu, 500-8384
JapanActive - Recruiting
Department of Cardiovascular Medicine Shinshu University School of Medicine
Nagano, 390-8621
JapanActive - Recruiting
Kansai Medical University,
Osaka, 573-1010
JapanActive - Recruiting
Medical Corporation Ouyuukai Tokorozawa Heart Center
Saitama, 359-1142
JapanActive - Recruiting
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033
JapanActive - Recruiting
Inselspital
Bern, 3010
SwitzerlandActive - Recruiting
CHUV
Lausanne, 1011
SwitzerlandActive - Recruiting
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