Status:
UNKNOWN
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
Lead Sponsor:
German Heart Institute
Collaborating Sponsors:
Novartis
Conditions:
Coronary Artery Disease
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare...
Eligibility Criteria
Inclusion
- Males or females, aged \>18 years.
- Patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary 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
- The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screening visit 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 mm diameter.
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT00426049
Start Date
October 1 2006
Last Update
January 24 2007
Active Locations (1)
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1
German Heart Institute Berlin
Berlin, State of Berlin, Germany, 13353