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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014176 |
Receipt No. | R000016451 |
Scientific Title | The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography |
Date of disclosure of the study information | 2014/06/06 |
Last modified on | 2015/10/10 |
Basic information | ||
Public title | The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography | |
Acronym | Scoring Compared to Conventional Ballooning on Everolimus-eluting Stent Expansion | |
Scientific Title | The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography | |
Scientific Title:Acronym | Scoring Compared to Conventional Ballooning on Everolimus-eluting Stent Expansion | |
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 | Stent expansion remains one of important predictors of restenosis and subacute thrombosis, even in use of the drug-eluting stent. In those patients, the role of different predilation strategies has yet to be established. Moreover, in the bioresorbable vascular scaffold era, sufficient lesion preparation is essential for their appropriate apposition. The aim of this study was to clarify the impact of lesion preparation using the scoring balloon on final stent expansion. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Rate of achieved to predicted stent area after deployment measured by optical coherent tomography (OCT) |
Key secondary outcomes | i) Binary stent restenosis at remote phase (QCA)
ii) Target vessel diameter/area after balloon angioplasty (OCT) iii) All-cause mortality, MACE (Major Adverse Cardiac Event) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Non-calcified coronary artery atherosclerotic lesions (calcification <50% of circumference) predilated with semi-compliant conventional balloon followed by a single 2.5-3.0 mm Cobalt-chromium Everolimus-eluting stent deployment under optical coherent tomography (OCT) guidance without post-stenting dilation. | |
Interventions/Control_2 | Non-calcified coronary artery atherosclerotic lesions (calcification <50% of circumference) predilated with semi-compliant Scoring balloon followed by a single 2.5-3.0 mm Cobalt-chromium Everolimus-eluting stent deployment under optical coherent tomography (OCT) guidance without post-stenting dilation. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Interventions/Control_9 | ||
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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 | Consecutive patients undergoing staged PCI in a single cardiovascular center.
(i) Referential vessel diameter estimated by OCT ((prox.+dist.)/2): 2.5-3.0 mm (ii) Lesion that is able to be covered by a single stent (iii) Lesion with calcification less than 50% of circumference |
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Key exclusion criteria | (i) Acute coronary syndrome
(ii) Pregnant patients (iii) Patients with malignant neoplasm whose life expectancies of less than 6 months (iv) Patients underwent prior PCI/CABG within 6 months (v) Patients with decompensated heart failure (vi) Patients with chronic kidney disease > stage 4 (vii) Patients with allergic reaction against ASA or clopidogrel |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nishiarai Heart Center Hospital | ||||||
Division name | Department of Cardiology | ||||||
Zip code | |||||||
Address | 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan | ||||||
TEL | +81358380730 | ||||||
juken1123@hotmail.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nishiarai Heart Center Hospital | ||||||
Division name | Department of Cardiology | ||||||
Zip code | |||||||
Address | 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan | ||||||
TEL | +81358380730 | ||||||
Homepage URL | |||||||
juken1123@hotmail.co.jp |
Sponsor | |
Institute | Nishiarai Heart Center Hospital |
Institute | |
Department |
Funding Source | |
Organization | Nishiarai Heart Center Hospital |
Organization | |
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Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 | |
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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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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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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=R000016451 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |