NCT01329237

COMPARE-II- Vasomotion and Imaging Substudy

Comparison of the Everolimus Eluting (XIENCE-V® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study The COMPARE II Trial Imaging and Vasomotion Substudy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Freiburg · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare strut coverage and neointimal thickness between everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation and to determine the coronary endothelial function after everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation by using supine bicycle exercise testing to assess coronary vasomotor response to exercise.

Detailed description

DESIGN: Imaging and vasomotion Substudy: 50 consecutive patients enrolled in the COMPARE II trial at the University of Fribourg Medical Center will undergo follow-up re-angiography 14 months after index procedure with assessment of Optical coherence tomography (OCT) and vasomotion testing. ENDPOINT SUBSTUDY (all at 14 months): Primary endpoint imaging: percentage of uncovered stent struts per lesion and mean neointimal thickness assessed by OCT. vasomotion: coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	dynamic physical exercise and OCT imaging	supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• First posted: 2011-04-05
• Last updated: 2011-04-05

Locations

1 site across 1 country: Switzerland