Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring DES (drug eluting stents), CAD (cornary artery disease), stent retrieval
Eligibility Criteria
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)
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00279006
First Posted
January 17, 2006
Last Updated
January 17, 2006
Sponsor
Foundation for Cardiovascular Research, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT00279006
Brief Title
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Official Title
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Foundation for Cardiovascular Research, Zurich
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the 3 drug-eluting stents presently marketed for intervention in the coronary artery with respect to the complications that may occur in case it becomes necessary to retract the stent during the intervention. It has been noted that stents carrying a drug for local application may be more difficult to retract than the more smooth bare metal stents.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
DES (drug eluting stents), CAD (cornary artery disease), stent retrieval
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Roffi, MD
Phone
+41 44 255 8573
Email
marco.roffi@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franz R Eberli, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
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