COMPARE-II- Vasomotion and Imaging Substudy

University of Freiburg50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

dynamic physical exercise and OCT imagingOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Cantonal HFR

Fribourg, Canton of Fribourg, Switzerland

RECRUITING

Outcomes

Primary Outcomes

percentage of uncovered stent struts per lesion assessed by OCT

Time frame: within 14 months after percutaneous coronary stent implantation

Secondary Outcomes

coronary vasomotor function

coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise

Time frame: within 14 months after stentimplantation

mean neointimal thickness assessed by OCT

Time frame: within 14 months after stent implantation

Central Contacts

Mario Togni, MD

CONTACT

++41-26-426-8130 mario.togni@unifr.ch

Stéphane Cook, MD

CONTACT

++41-26-426-8130 stephane.cook@unifr.ch

Data from ClinicalTrials.gov

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