COMPARE-II- Vasomotion and Imaging Substudy

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Other: dynamic physical exercise and OCT imaging

• Registration Number: NCT01329237
• Lead Sponsor: University of Freiburg

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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-04-04
• Last Update Submitted: 2011-04-04
• Study First Posted: 2011-04-05
• Last Update Posted: 2011-04-05
• Primary Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dynamic physical exercise OCT	dynamic physical exercise and OCT imaging	dynamic physical exercise and optical coherence tomography imaging

Primary Outcome Measures

Name	Time	Method
percentage of uncovered stent struts per lesion assessed by OCT	within 14 months after percutaneous coronary stent implantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Cantonal HFR; 🇨🇭 Fribourg, Switzerland