- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279006
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients in whom DES implantation is planned will be randomized to one of the 3 commercially available stents (i.e., Cypher, Taxus-Liberté, Endeavor).
Sealed envelopes will be used for randomization purposes. Should additional stents be required in the same patient for the same or other lesions, another stent of the same type of stents will be implanted.
The following assessments will be made:
- Unblinded subjective operator assessment based on a questionnaire. The questionnaire will include questions on problems encountered during stent-balloon retrieval, special maneuvers performed (e.g., retrieval of the catheter during device removal, and possible complications associated with device retrieval).
Blinded measurements of following parameters:
- Minimal and maximal distance between the tip of the guiding catheter and the proximal stent end during stent-balloon retrieval.
- Minimal and maximal distance between the tip of the guidewire and the distal portion of the stent during stent-balloon retrieval.
- To do so the retrieval of the stent-balloon will be documented on ciné-angiography. The measurements will be performed by a qualified technician/physician blinded to the type of device used.
Clinical endpoints:
d. In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
e. Myocardial infarction defined as creatine kinase MB-isoform [CK-MB] ≥3x upper limit of normal within 24 hours of the procedure or ≥2x upper limit of normal after 24 hours of the procedure in the presence of new ischemic symptoms.
- Target enrollment of 150 patients
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marco Roffi, MD
- Phone Number: +41 44 255 8573
- Email: marco.roffi@usz.ch
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with a planned angiography and percutane coronary intervention
- Age 18 years or above
- Informed consent to PCI and to participation in this trial
Exclusion Criteria:
- Patients who after angiography are deemed not suitable for stent implant (operators discretion)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
|
Myocardial infarction defined as creatine kinase MB-isoform [CK-MB] ≥3x upper limit of normal within 24 hours of the procedure or ≥2x upper limit of normal after 24 hours of the procedure in the presence of new ischemic symptoms.
|
Collaborators and Investigators
Investigators
- Study Director: Franz R Eberli, MD, University Hospital, Zürich
Study record dates
Study Major Dates
Study Start
Study Completion
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
Other Study ID Numbers
- EK-12006
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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