Percutaneous Coronary Intervention Clinical Trial
— BEYOND-IIOfficial title:
Comparison of the Safety and Efficacy Between Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) and Paclitaxel-Eluting Balloon (Bingo) in Coronary Bifurcation Lesions: A Prospective, Multicenter, Randomized, Controlled Trial (BEYOND II)
To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide the clinical data for the formal application in China and for the approvement of China marketing.
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | October 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Subjects that participate in this study must fulfill all the following criteria: General 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. Angiographic inclusion criteria: 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: If subjects fulfill any of below criteria, this subject shall be exclude from this study. General 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; Angiographic exclusion criteria 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; |
Country | Name | City | State |
---|---|---|---|
China | Beijing Anzhen Hospital Capital Medical University | Beijing | |
China | First Bethune Hospital of Jilin University | Changchun | Jilin |
China | The Second Hospital of Dalian University | Dalian | Liaonin |
China | Daqing Oil General Hospital | Daqing | Heilongjiang |
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 | First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan |
China | Nanjing First Hospital | Nanjing | Jiangsu |
China | Shanghai East Hospital, | Shanghai | |
China | General Hospital of Northern Theater Command | Shengyang | Liaonin |
China | The First Hospital of China Medical University | Shengyang | Liaonin |
China | Tianjin Chest Hospital | Tianjin | |
China | Wuhan Asian Heart Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
CCRF Inc., Beijing, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | angiographic endpoints-late loss of side branch | assess in millimeter | 9 months after operation | |
Other | angiographic endpoints-minimal lumen diameter (MLD) of side branch | assess in millimeter | 9 months after operation | |
Other | angiographic endpoints-diameter stenosis (DS) | assess in percentage | 9 months after operation | |
Other | angiographic endpoints-angiographic binary restenosis (ABR) | assess in percentage | 9 months after operation | |
Primary | late lumen loss | in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography) | 9 months after operation | |
Secondary | device success | define as dilation success in the side branch lesion by study balloon or control ballon, that is the residual stenosis =50%,TIMI (Thrombolysis In Myocardial Infarction) 3 flow and without type C or above dissection | immediately post procedure | |
Secondary | clinical success | define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success. | 1 month after operation | |
Secondary | device oriented composite endpoints (DoCE) | that is TLF, define as the composite endpoint include cardiac death, target vessel myocardial infarction and ischemic driven target lesion revascularization (ID-TLR) | 1, 6, 9, 12 month after operation | |
Secondary | patients oriented composite endpoints (PoCE) | define as a composite endpoints of all cause death, any myocardial infarction and any revascularization | 1, 6, 9, 12 month after operation | |
Secondary | all cause death | include cardiac death, vascular death, noncardiovascular death | 1, 6, 9, 12 month after operation | |
Secondary | myocardial infarction (MI) | target vessel MI, non-target vessel MI | 1, 6, 9, 12 month after operation | |
Secondary | target lesion revasculation | ischemic driven, non-ischemic driven | 1, 6, 9, 12 month after operation | |
Secondary | target vessel revasculation | ischemic driven, non-ischemic driven | 1, 6, 9, 12 month after operation | |
Secondary | any coronary revasculation | 1, 6, 9, 12 month after operation | ||
Secondary | thrombosis in the side branch lesion | 1, 6, 9, 12 month after operation |
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