Phase
Condition
Coronary Artery Disease
Heart Disease
Vascular Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females, aged >18 years.
Patients with coronary artery disease who are scheduled for coronary intervention withbare metal stent placement for treatment of de novo or first restenosis in a nativecoronary artery.
Target lesion must be in a native coronary vessel of 2.25 – 4.0 mm size.
Target lesion has to be of less than or equal to 25 mm length.
Tandem lesion may be included as long as:
overall length is less than or equal to 25 mm
tandem lesion will be treated with one stent and counted as one lesion.
Exclusion
Exclusion Criteria: The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screeningvisit prior to coronary intervention). If an exclusion criterion occurred afterwards, e.g.,during the coronary intervention, the patient must be excluded from the study.
Target lesion has a reference vessel size of less than 2.25 or more than 4.0 mmdiameter.
Target lesion is a total occlusion or located at a bifurcation.
Treatment affords implantation of more than one stent per treated lesion.
Target lesion was already treated by brachytherapy.
Target lesion has one or more of the following criteria:
Left main lesion
Ostial lesion of the RCA
Located at less than 2 mm after the origin of the LAD or RCX. Other protocol defined inclusion/exclusion criteria may apply.
Study Design
Connect with a study center
German Heart Institute Berlin
Berlin, 13353
GermanyActive - Recruiting
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