COMPARE-II- Vasomotion and Imaging Substudy (COMPARE-IT)

University of Freiburg

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Other: dynamic physical exercise and OCT imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01329237

COMPARE-II-Imaging

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

dynamic physical exercise OCT

Other group

Description:

dynamic physical exercise and optical coherence tomography imaging

Treatment:

Other: dynamic physical exercise and OCT imaging