Unique ID issued by UMIN | UMIN000022130 |
---|---|
Receipt number | R000025508 |
Scientific Title | Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography |
Date of disclosure of the study information | 2016/04/28 |
Last modified on | 2017/11/10 14:24:39 |
Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography
Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography
Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography
Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography
Japan |
ischemic heart disease
Cardiology |
Others
NO
To evaluate the Synergy stent coverage at 2 weeks after implantation for ischemic heart disease with optical coherence tomography
Efficacy
Exploratory
Phase II
Percentage of covered struts at 2 weeks after Synergy implantation
1) Percentage of apposed struts at 2 weeks after Synergy implantation
2) Relation between patients background and the percentage of covered or apposed struts
3) The evaluation of mean stent area, lumen area, neointimal area, and relation between patients background and them.
4) Existence of thrombus, heterogeneity of neointima, neovascularization, stent edge dissection, and relation between patients background and them
5) Percentage of covered struts in the overlapping segments
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Evaluation for neointima with optical coherence tomography (OCT) imaging catheter at 2 weeks after Synergy implantation
20 | years-old | <= |
85 | years-old | > |
Male and Female
1) Patients who underwent percutaneous coronary intervention (PCI) for ischemic heart disease, and implanted Synergy stent
2) Patients who plan to undergo additional PCI for residual lesion 2 weeks later
1) Patients with impaired renal function (eGFR <50ml/min/1.73m2)
2) Patients with severe heart failure (LVEF <30% or NYHA class > 3)
30
1st name | |
Middle name | |
Last name | Yoshio Kobayashi |
Chiba University Hospital
Department of Cardiovascular Medicine
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-222-7171
tsuchiya-chiba@umin.ac.jp
1st name | |
Middle name | |
Last name | Norikiyo Oka |
Chiba University Hospital
Department of Cardiovascular Medicine
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-222-7171
norikiyo.oka@ma.point.ne.jp
Chiba University Hospital, Department of Cardiovascular Medicine
None
Self funding
NO
千葉大学医学部附属病院(千葉県)
2016 | Year | 04 | Month | 28 | Day |
Unpublished
No longer recruiting
2016 | Year | 04 | Month | 20 | Day |
2016 | Year | 05 | Month | 06 | Day |
2016 | Year | 04 | Month | 28 | Day |
2017 | Year | 11 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025508
Research Plan | |
---|---|
Registered date | File name |
2017/11/10 | 臨床試験実施計画書 ver7_20161216.docx |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |