Status Approved
First Submitted Date
2017/12/13
Registered Date
2018/08/13
Last Updated Date
2018/07/18
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003082 |
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Unique Protocol ID | MD16034 |
Public/Brief Title | Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions. |
Scientific Title | Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions. |
Acronym | SPOT trial |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | MD16034-002 |
Approval Date | 2016-08-10 |
Institutional Review Board Name | Korea University Guro hospital Institutional Review Board |
Institutional Review Board Address | IRB Office, 4th Floor, Life Research Center, Korea University Guro Hospital, 148, Guro-dong, Guro-gu, Seoul, Korea |
Institutional Review Board Telephone | 02-2626-1858 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seung Woon Rha |
Title | Professor |
Telephone | +82-2-2626-3020 |
Affiliation | Koera University Guro Hospital |
Address | Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea |
Contact Person for Public Queries | |
Name | Seung Woon Rha |
Title | Professor |
Telephone | +82-2-2626-3020 |
Affiliation | Koera University Guro Hospital |
Address | Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea |
Contact Person for Updating Information | |
Name | Seung Woon Rha |
Title | Professor |
Telephone | +82-2-2626-3020 |
Affiliation | Koera University Guro Hospital |
Address | Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea |
4. Status
Study Site | Multi-center Number of center : 9 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-09-30 Actual | |
Target Number of Participant | 470 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Cheongju ST.Mary's Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-11-23 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Hallym University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-03-02 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Soon Chun Hyang University Hospital Cheonan | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-03-14 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | The Catholic University of Korea, St. Paul's Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-09-15 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | Chonnam National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-12-20 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Eulji University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-09-30 , | |
Recruitment Status by Participating Study Site 7 | ||
Name of Study | Seoul National University Bundang Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-10-23 , | |
Recruitment Status by Participating Study Site 8 | ||
Name of Study | Kangwon National University Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2018-10-01 , | |
Recruitment Status by Participating Study Site 9 | ||
Name of Study | Koera University Guro Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-10-25 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Medtronic Korea |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Koera University Guro Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | 1. Purpose of Study The purpose of this study was to evaluate the efficacy and safety of intracoronary stent implantation for the treatment of diffuse long-term lesions, based on angiographic findings, with stent insertion centered on the most severe stenosis, We aimed to compare the clinical results up to 1 year among patients undergoing extensive stenting without residual lesions by performing a total stenting in the area. 2. Research Background Stent length was known to be a cause of strong stent restenosis in the past, but the effect of stent length on stent restenosis after the emergence of drug-eluting stent was greatly reduced. , It is recommended that large stents be inserted where there is no atherosclerosis as much as possible in fear of stent length during drug-releasing stent implantation. An intravenous ultrasound intervention should be considered as an ideal stent insertion site of less than 40% plaque burden Is recommended. However, it has been reported that a long stent implantation of 31.5 mm or longer may increase the risk of stent thrombosis in a diffuse long lesion, which leads to an excessively long stent length. In the case of a diffuse lesion with a stent length of 80 ± 20 mm, a 6-month restenosis rate of more than 19% was reported.In addition, the use of an overstaged stent implantation for long- And 23% of infarcts, suggesting concern about the safety of long stenting in long lesions. In addition, the results of the second- or third-generation DES recently introduced due to the rapid development of DES are less known. In contrast, stent implantation with a partial bovine stent placement, which would leave a residual lesion on both ends of the stent, is associated with restenosis or intra-segmental restenosis. The larger diameter of the network compared to the distal and proximal portions of the stent, Is known to be a predictor of endosteal stenosis. In addition, stent thrombosis is the most common cause of stent thrombosis. According to Demosthenes G, 2009, preliminary studies have shown that the use of a first-generation stent for lower-stent restenosis and angina pectoris recurrence is more advantageous than for long-stenting stent implantation, but a clearer result is required. Therefore, in the actual clinical practice, the choice of the two procedures is difficu- larly selected by the practitioner according to the individual clinical situation in the diffuse long lesion. 3. Research hypothesis In a similar study of the study, Am J Cardiol 2009; 104: 786-790 by DEMOSTHENES G. KATRITSIS reported that the spot stenting group compared to the entire stenting group There is no significant difference in 1-year target vessel failure rate. The overall hypothesis was that when the 1-year target vessel failure rate was 7% in the control group, the entire stenting group, the allergic hypothesis was "one-year target vessel failure rate in the spot stenting group, The difference in the 1-year target vessel failure rate of stenting will be within 6% of the non-inferiority margin. " |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase4 |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | In angio-guided angio-guided stent implantation with diffuse long lesion, stent placement with the stenosis centered on the most severe stenosis was performed and spot stenting was performed, leaving a residual lesion in the proximal or distal portion of the stent. And to compare the clinical results between the patients who underwent extensive stenting and the patients who underwent total stenting without residual lesion. |
Number of Arms | 2 |
Arm 1 |
Arm Label Spot Stenting group |
Target Number of Participant 235 |
|
Arm Type Experimental |
|
Arm Description Stent insertion with angio-guided angiography in the diffuse long lesion with stent insertion centered on the most severe stenosis in the proximal or distal portion of the stent |
|
Arm 2 |
Arm Label Entire stenting group |
Target Number of Participant 235 |
|
Arm Type Active comparator |
|
Arm Description In angio-guided angio-guided diffuse long lesions, extensive stenting was performed in the entire area of the lesion centered on the most severe stenosis, resulting in complete stenting without residual lesion. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I20.88)Other forms of angina pectoris |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description 1. Age Only patients with stable angina or unstable angina over 19 years 2. Reference diameter ≥ 2.5 mm lesion length ≥ 25 mm 3. De novo lesions with% Diameter stenosis ≥50% 4. Patient with Core lesion for spot stenting For definitions of core lesions, see Clinical Trial Methods. |
|
Exclusion Criteria |
1. Ascitic (aspirin), clopidogrel (Clopidogrel) and anti-platelet agents, such as those who are contraindicated 2. Left-sided lesions (left main lesion, internal diameter stenosis (diameter stenosis) ≥50%) 3. A recent hematologic disease or white blood cell count of 3000 / mm3 and / or platelet count of 100,000 / mm3. Who show less 4. Severe epicardial disease with a longevity of less than 1 year 5. Those who plan to perform two stenting operations on branch vessels and branch lesions with basilar lesions 6. Patients who underwent emergency stenting after a diagnosis of myocardial infarction within 24 hours (STEMI, NSTEMI can be enrolled after 24 hours) 7. Who can not comply with the research plan |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | cardiac death |
|
Timepoint | target vessel failure for 12 months |
|
Primary Outcome(s) 2 | ||
Outcome | Target vessel myocardial infarction |
|
Timepoint | target vessel failure for 12 months |
|
Primary Outcome(s) 3 | ||
Outcome | STEMI and NSTEMI- Including periprocedural myocardial infarction |
|
Timepoint | target vessel failure for 12 months |
|
Primary Outcome(s) 4 | ||
Outcome | Ischemic driven target vessel revascularization |
|
Timepoint | target vessel failure for 12 months |
|
Secondary Outcome(s) 1 | ||
Outcome | All death |
|
Timepoint | for 12 months |
|
Secondary Outcome(s) 2 | ||
Outcome | STEMI and NSTEMI-periprocedural MI |
|
Timepoint | for 12 months |
|
Secondary Outcome(s) 3 | ||
Outcome | Target lesion revascularization (TLR) |
|
Timepoint | for 12 months |
|
Secondary Outcome(s) 4 | ||
Outcome | target vessel revascularization (Non-TVR), |
|
Timepoint | for 12 months |
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Secondary Outcome(s) 5 | ||
Outcome | Stent thrombosis |
|
Timepoint | for 12 months |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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