Phase
Condition
Thrombosis
Myocardial Ischemia
Coronary Artery Disease
Treatment
N/AClinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of angina pectoris as defined by Canadian Cardiovascular SocietyClassification (CCS I, II, III, IV) OR unstable angina pectoris (BraunwaldClassification B&C, I-II-III) OR patients with documented silent ischemia;
Single treatment of de novo lesion in a coronary artery which can be appropriatelycovered by a study stent up to 23mm in length in patients with single or multivesseldisease; patients with multiple lesions can be included only if the other lesions aresuccessfully treated before the target lesion;
Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
Target lesion is located in a native coronary artery with a maximum lesion length thatcan be adequately covered by a single 23 mm stent;
Target lesion stenosis is > 50% and < 100% (visual estimate).
Exclusion
Exclusion Criteria:
A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless theCK and CK-MB enzymes are back to normal;
Unprotected left main coronary disease with more than 50% stenosis;
Significant (>50%) stenoses proximal or distal to the target lesion that might requirerevascularization or impede runoff;
Have an ostial target lesion;
Angiographic evidence of thrombus within target lesion;
Calcified lesions which cannot be successfully predilated;
Ejection fraction less than 30%;
Totally occluded vessel (TIMI 0 level);
Direct Stenting;
Study Design
Study Description
Connect with a study center
Cardiothoracic Center Liverpool
Liverpool, L14 3PE
United KingdomSite Not Available
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