Clinical trial NCT01329237: COMPARE-II- Vasomotion and Imaging Substudy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: drug-eluting stent
coronary endothelial function
coronary imaging
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of uncovered stent struts per lesion assessed by OCT
timeFrame: within 14 months after percutaneous coronary stent implantation
Secondary outcomes:
measure: coronary vasomotor function
timeFrame: within 14 months after stentimplantation
measure: mean neointimal thickness assessed by OCT
timeFrame: within 14 months after stent implantation
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: Hopital Cantonal HFR
Study officials:
affiliation: University of Fribourg, Switzerland
name: Mario Togni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Fribourg, Switzerland
name: Stéphane Cook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Cantonal HFR, Fribourg, Switzerland
name: Jean-Christophe Stauffer, MD
role: STUDY_CHAIR
affiliation: Hopital Cantonal HFR, Fribourg, Switzerland
name: Jean-Jacques Goy, MD
role: STUDY_CHAIR
affiliation: Hopital Cantonal HFR, Fribourg, Switzerland
name: Gérard Baeriswyl, MD
role: STUDY_CHAIR
affiliation: Maasstad Ziekenhuis, Rotterdam, The Netherlands
name: Pieter C Smits, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: