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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000011898 |
Receipt No. | R000013901 |
Scientific Title | Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) - |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2013/09/27 |
Basic information | ||
Public title | Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) -
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Acronym | RI-ZES OCT Study | |
Scientific Title | Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) -
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Scientific Title:Acronym | RI-ZES OCT Study | |
Region |
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Condition | ||
Condition | Ischemic Heart Disease, Coronary Artery Disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate a possible reduction in the duration of post-procedural double antiplatelet therapy through observation of morphological changes in neointima at the site of stenting with the use of OCT at 1- and 9-month after Resolute Integrity zotarolimus-eluting stent implantation. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15frames) over the entire stent length at 1 and 9 months after stenting.
[Qualitative analysis] - Number of stent struts analyzed - Neointimal coverage (neointimal coverage in stent struts) - Stent incomplete apposition (post-procedural incomplete stent apposition) - Prolapse (plaque prolapse) - Thrombus (thrombus around stent struts) - Dissection (coronary dissection) [Quantitative analysis] - Neointimal thickness (NIT) |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The study will enroll patients who are eligible for treatment with drug-eluting stents and who are scheduled for staged PCI. The Resolute Integrity stent will be implanted in lesions responsible for index PCI in 50 patients scheduled for staged PCI. This clinical study will be conducted with minimal exclusion criteria to reflect real-world clinical practice in the study. | |||
Key exclusion criteria | - Unprotected LMT lesions
- Patients with cardiogenic shock - Patients who have decompensated hypotension or are intubated, and those with cardiac failure requiring IABP - Patients treated with debulking, such as Rotablator and DCA - Patients with renal impairment (Cre ≥ 1.5) - Proximal lesions within 10 mm from the coronary ostia (OCT not available) - Patients from whom no written consent is obtained - Other patients considered ineligible for this clinical study by the investigator |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Hospital Organization
Okayama Medical Center |
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Division name | Division of Cardiovascular Medicine | ||||||
Zip code | |||||||
Address | 1711-1 Tamasu, Kita-ku, Okayama 701-1192, Japan | ||||||
TEL | +81862949911 | ||||||
munemasa@okayama3.hosp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Hospital Organization Okayama Medical Center | ||||||
Division name | Division of Cardiovascular Medicine | ||||||
Zip code | |||||||
Address | 1711-1 Tamasu, Kuta-ku, Okayama 701-1192, Japan | ||||||
TEL | +81862949911 | ||||||
Homepage URL | |||||||
munemasa@okayama3.hosp.go.jp |
Sponsor | |
Institute | Division of Cardiovascular Medicine, National Hospital Organization Okayama Medical Center |
Institute | |
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Funding Source | |
Organization | None |
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Category of Funding Organization | Other |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Other | |
Other related information | OCT imaging analysis:
A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15 frames) over the entire stent length at 1 and 9 months after stenting. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013901 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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