Coronary Artery Disease
Conditions
Keywords
drug-eluting stent, coronary endothelial function, coronary imaging
Brief 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.
Interventions
OTHERdynamic physical exercise and OCT imaging
supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent
Sponsors
University of Freiburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient enrolled in the COMPARE II trial with successful stent implantation and absence of binary restenosis or severe progression of coronary artery disease at 14 months follow-up. * Patient consent to undergo a non-scheduled follow- up angiography with imaging study and bicycle exercise testing
Exclusion criteria
1. Inability to provide informed consent 2. Inability to perform a supine bicycle exercise stress test 3. Binary in stent restenosis of the target vessel 4. Acute Coronary Syndrome, Acute Myocardial Infarction 5. Patients with stent thrombosis following the index procedure 6. Female of childbearing potential ( age ≤ 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy 7. Known intolerance to heparin, contrast material 8. History of bleeding diathesis or known coagulopathy 9. Age ≥ 80 years 10. Hemodynamic instability 11. Renal failure (creatinine clearance ≤ 40 ml/min) 12. OCT / IVUS technically not feasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of uncovered stent struts per lesion assessed by OCT | within 14 months after percutaneous coronary stent implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| coronary vasomotor function | within 14 months after stentimplantation | coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise |
| mean neointimal thickness assessed by OCT | within 14 months after stent implantation | — |
Countries
Switzerland
Contacts
Primary ContactMario Togni, MD
Backup ContactStéphane Cook, MD
Outcome results
None listed