NCT00473499

PEPCAD III Substudy: Stem Cell Mobilization

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, B.Braun) will undergo the same diagnostic procedures.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DEBlue vs Cypher vs BMS	BMS vs DES vs DEB+BMS

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-03-01
• Completion: 2009-11-01
• First posted: 2007-05-15
• Last updated: 2010-06-30

Locations

1 site across 1 country: Germany