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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000048490 |
Receipt No. | R000055258 |
Scientific Title | Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/27 |
Basic information | ||
Public title | Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
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Acronym | Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study | |
Scientific Title | Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study | |
Scientific Title:Acronym | Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study | |
Region |
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Condition | ||
Condition | coronary artery disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to investigate the risk factor for stent failure after drug-eluting stent implantation for calcified nodule. |
Basic objectives2 | Others |
Basic objectives -Others | investigation of risk factor |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Target lesion revascularization |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) patients who underwent OCT-guided PCI from August 2013 to October 2020
(2)patients whose culprit lesion had CN detected by pre PCI OCT |
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Key exclusion criteria | (1)patients who were not implanted drug-eluting stents (DES) (those treated with drug-coated balloon [DCB], and those treated with percutaneous old balloon angioplasty [POBA] or rotation atherectomy [RA] alone)
(2)those with in-stent restenosis (3)those with coronary artery bypass grafted lesions (4)those with insufficient OCT data quality (5)those who died within a year after the index PCI |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Division of Cardiovascular Medicine | ||||||
Zip code | 6500017 | ||||||
Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe | ||||||
TEL | 0783825846 | ||||||
hotake@med.kobe-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Division of Cardiovascular Medicine | ||||||
Zip code | 6500017 | ||||||
Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe | ||||||
TEL | 0783825846 | ||||||
Homepage URL | |||||||
tomohamachi@yahoo.co.jp |
Sponsor | |
Institute | Kobe University |
Institute | |
Department |
Funding Source | |
Organization | Kobe University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kobe university hospital clinical and translational research center |
Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe |
Tel | 0783826669 |
ccrspprt@med.kobe-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 120 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Multicenter, retrospective, observational study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055258 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |