COMPARE-II- Vasomotion and Imaging Substudy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: dynamic physical exercise and OCT imaging


Participation Criteria
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Eligibility Criteria
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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: Inability to provide informed consent Inability to perform a supine bicycle exercise stress test Binary in stent restenosis of the target vessel Acute Coronary Syndrome, Acute Myocardial Infarction Patients with stent thrombosis following the index procedure Female of childbearing potential ( age ≤ 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy Known intolerance to heparin, contrast material History of bleeding diathesis or known coagulopathy Age ≥ 80 years Hemodynamic instability Renal failure (creatinine clearance ≤ 40 ml/min) OCT / IVUS technically not feasible

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dynamic physical exercise OCT<br>dynamic physical exercise and optical coherence tomography imaging | Other: dynamic physical exercise and OCT imaging<br>* supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of uncovered stent struts per lesion assessed by OCT |  | within 14 months after percutaneous coronary stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary vasomotor function | coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise | within 14 months after stentimplantation | 
| mean neointimal thickness assessed by OCT |  | within 14 months after stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting stent, coronary endothelial function, coronary imaging