Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473499
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2007-05-14
Brief Title:
PEPCAD III Substudy Stem Cell Mobilization
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
Paclitaxel-Eluting PTCA-Balloon in Combination With the Coroflex Blue Stent vs the Sirolimus Coated Cypher Stent in the Treatment of Advanced Coronary Artery Disease - Substudy HomburgSaar
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
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:
PEPCADIIIsub
Brief Summary:
The aim of the PEPCAD III substudy is to assess the efficacy of the Paclitaxel-eluting DEBlue stent system in the treatment of stenoses in native coronary arteries compared to the Sirolimus-eluting Cypher stent by intravascular ultrasound IVUS and to study the influence of both devices on endothelial function coronary flow reserve and stem cell mobilization
Detailed Description:
The aim of the PEPCAD III substudy is to assess the efficacy of the DEBlue Paclitaxel-eluting stent system in the treatment of stenoses in native coronary arteries compared to the Sirolimus-eluting Cypher stent by intravascular ultrasound IVUS and to study the influence of both devices on endothelial function coronary flow reserve and stem cell mobilization This study is a prospective randomized single-center two-armed phase-II study During the PEPCAD III trial 40 patients of the Homburg Saar center will be randomly assigned to ei-ther one of the treatment groups 20 patients treated with DEBlue 20 patients with Cypher Patients with stable or selected forms of unstable angina or documented ischemia due to a significant lesion in a native coronary artery will be included Vessels may not supply an en-tirely infarcted myocardial area Additional 20 patients receiving uncoated stents Coroflex Blue BBraun will undergo the same diagnostic procedures
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