Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279006
Status:
UNKNOWN
Last Update Posted:
2006-01-19
First Post:
2006-01-17
Brief Title:
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter A Randomized Comparison
Sponsor:
Foundation for Cardiovascular Research Zurich
Organization:
Foundation for Cardiovascular Research Zurich
Study Overview
Official Title:
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter A Randomized Comparison
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 eg retrieval of the catheter during device removal and possible complications associated with device retrieval
Blinded measurements of following parameters
1 Minimal and maximal distance between the tip of the guiding catheter and the proximal stent end during stent-balloon retrieval
2 Minimal and maximal distance between the tip of the guidewire and the distal portion of the stent during stent-balloon retrieval
3 To do so the retrieval of the stent-balloon will be documented on ciné-angiography The measurements will be performed by a qualified technicianphysician 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
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 eg retrieval of the catheter during device removal and possible complications associated with device retrieval
Blinded measurements of following parameters
1 Minimal and maximal distance between the tip of the guiding catheter and the proximal stent end during stent-balloon retrieval
2 Minimal and maximal distance between the tip of the guidewire and the distal portion of the stent during stent-balloon retrieval
3 To do so the retrieval of the stent-balloon will be documented on ciné-angiography The measurements will be performed by a qualified technicianphysician 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None