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PEPCAD III Substudy: Stem Cell Mobilization — PEPCADIIIsub  

Coronary Artery Disease Clinical Trial

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 Homburg/Saar

Clinical Trial 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.

Clinical Trial 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, B.Braun) will undergo the same diagnostic procedures. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00473499
Study type Interventional
Source University Hospital, Saarland
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2007
Completion date November 2009
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