The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
NCT ID: NCT03820622
Last Updated: 2019-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2019-03-31
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DIOR group
in this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
Bingo group
in this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo)
Paclitaxel-Eluting Balloon (Bingo)
patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)
Interventions
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Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
Paclitaxel-Eluting Balloon (Bingo)
patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)
Eligibility Criteria
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Inclusion Criteria
1. Age from 18 to 80 years old, man or non-pregnant woman;
2. Subjects with stable or unstable angina, old myocardial infarction, or asymptomatic ischemic evidence with clinical diagnosis;
3. Subjects without contraindications of coronary artery bypass grafting (CABG);
4. Subjects must agree to the follow up of angiographic and clinical required in the study;
5. Subjects are able to understand the purpose of this study, provide an informed consent to show recognize to the study protocol.
1. One or two bifurcation lesions, locate in different epicardial vessels, the bifurcation lesion in each epicardial vessel can not over 1; or 1 de nove coronary artery bifurcation can be included after 1 lesion of non-target vessel has been successfully treated by PCI (Percutaneous Coronary Intervention);
2. Residual diameter stenosis in main branch (MB) ≥ 70% (visually), or ≥ 50% simultaneously with clinical symptom, and the diameter stenosis in side branch (SB) ≥ 50% (visually); and the main branch's residual stenosis ≤ 20% with TIMI 3 flow post the stent placement, while the side branch diameter stenosis ≥ 70% post the MB stenting;
3. Fulfill the definition of truly bifurcation lesions by Medina type (1.1.1、1.0.1、0.1.1);
4. Diameter in side branch between ≥ 2.5 mm to ≤ 4.00 mm (visually) and lesion length ≤ 26 mm (visually);
5. Each side branch of the bifurcation lesion can be treated by only 1 study drug coated balloon (DCB) or control DCB, and the lesion shall be fully covered by the DCB ( the distal end of the balloon shall exceed the lesion at least 1 mm).
Exclusion Criteria
1. Pregnant or lactating women
2. Any newly myocardial infarction onset within 1 week or, the myocardial enzyme of CK (Creatine Kinase) or CK-MB does not return to normal level after any myocardial infarction;
3. Cardiogenic shock;
4. Severe chronic heart failure, NYHA (New York Heart Association) ≥ grade III, or left ventricular ejection fraction \< 35% (accessed by echocardiography or left ventricular angiography)
5. Patients with renal insufficiency (estimated glomerular filtration rate \< 30ml/min/1.73m2 calculated by MRDR (Modification of Diet in Renal Disease) formula or subject is receiving renal dialysis)
6. Having a history of hemorrhagic diseases such as cerebral hemorrhage, gastrointestinal hemorrhage; stroke occurring or any situation occurring that may lead to prolongation of anticoagulation therapy within 6 months before operation;
7. History of coronary or peripheral vascular interventional therapy within 12 months before hospitalized.
8. Patients are allergic or contraindicate to contrast agent, paclitaxel, heparin, antiplatelet and anticoagulant drug;
9. The Subjects have other serious diseases and the expected survival is less than 12 months;
10. Investigators determine the subjects' compliance is poor, cannot complete the study as required;
1. Main branch lesion or non-target lesion(s) located in left main;
2. Main branch lesion or non-target lesion(s) is triple vessel lesion, all need to be treated;
3. Side branch lesion is triple bifurcation or multiple bifurcation;
4. Main branch lesion located within 3 mm of the origin of the LAD (Left Anterior Descending), LCX (Left Circumflex Branch) or RCA (Right Coronary Arter);
5. Side branch target lesion is diffusion lesion and length \> 26mm; or a ≥90% stenosis lesion is found near the SB lesion within 5 mm;
6. Side branch as the target vessel has received any interventional treatment;
7. Side branch as the target lesion or target vessel involve in aneurysm;
8. The lesion in side branch or main branch is total occlusive lesions, with TIMI blood flow of grade 0;
9. Side branch target lesion is moderate or heavy calcified or target vessel excessive tortuosity, which is unfavorable for interventional treatment anatomically;
10. Subject's blood pressure is too low to be injected with nitroglycerin ≥ 100 ug, this subject can not be included in the study;
11. Side branch target lesion can not reach the following outcomes, after the completely balloon pre-dilatation:
1\) Residual stenosis (DS %) is ≤50% (visually); 2) TIMI Grade-3 flow ((visually); 3) No angiographic complications (e.g., no-reflow, distal embolization, side branch closure) 4) No dissections NHLBI grade C-F;
18 Years
80 Years
ALL
No
Sponsors
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CCRF Inc., Beijing, China
INDUSTRY
Responsible Party
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Principal Investigators
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Yaling Han, professor
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Locations
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Daqing Oil General Hospital
Daqing, Heilongjiang, China
Wuhan Asian Heart Hospital
Wuhan, Hubei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian University
Dalian, Liaoning, China
General Hospital of Northern Theater Command
Shengyang, Liaoning, China
The First Hospital of China Medical University
Shengyang, Liaoning, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Anzhen Hospital Capital Medical University
Beijing, , China
Shanghai East Hospital,
Shanghai, , China
Tianjin Chest Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Hui Li, professor
Role: primary
Xi Su, professor
Role: primary
Saoliang Chen, professor
Role: primary
Han Yaling, professor
Role: primary
Geng wang, professor
Role: backup
Yingxian Sun
Role: primary
Guosheng Fu, professor
Role: primary
Wang jian'an, professor
Role: primary
Qi Zhang, professor
Role: primary
Hongliang Cong, professor
Role: primary
Other Identifiers
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DIOR 2nd -1706
Identifier Type: -
Identifier Source: org_study_id