- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00426049
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
Monocenter, Double Blinded, Prospective, Randomized Placebo Controlled Study Investigating Prevention of Major Adverse Cardiac Events (MACEs) Within 6 Months by Systemic Treatment With Everolimus After Coronary Intervention With Bare Metal Stents in Patients With Significant Coronary Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Eckart Fleck, Professor
- Phone Number: 2400 +49-(0)30-4593
- Email: fleck@dhzb.de
Study Locations
-
-
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Berlin, Germany, 13353
- Recruiting
- German Heart Institute Berlin
-
Principal Investigator:
- Eckart Fleck, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Major adverse cardiac events (MACEs)within 6 months
|
Secondary Outcome Measures
Outcome Measure |
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MACEs within 30 days
|
Quantitative angiographic observations within the vessel after 6 months
|
TLR and TVR after 6 months
|
Drug safety and tolerability for 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eckart Fleck, Professor, German Heart Institute
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Stenosis
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Coronary Restenosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Everolimus
Other Study ID Numbers
- CRAD001ADE07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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