The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
BEYOND-II
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)
1 other identifier
interventional
220
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJanuary 31, 2019
January 1, 2019
3.2 years
January 24, 2019
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
late lumen loss
in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
9 months after operation
Secondary Outcomes (10)
device success
immediately post procedure
clinical success
1 month after operation
device oriented composite endpoints (DoCE)
1, 6, 9, 12 month after operation
patients oriented composite endpoints (PoCE)
1, 6, 9, 12 month after operation
all cause death
1, 6, 9, 12 month after operation
- +5 more secondary outcomes
Other Outcomes (4)
angiographic endpoints-late loss of side branch
9 months after operation
angiographic endpoints-minimal lumen diameter (MLD) of side branch
9 months after operation
angiographic endpoints-diameter stenosis (DS)
9 months after operation
- +1 more other outcomes
Study Arms (2)
DIOR group
EXPERIMENTALin this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
Bingo group
ACTIVE COMPARATORin this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo)
Interventions
patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)
Eligibility Criteria
You may qualify if:
- Subjects that participate in this study must fulfill all the following criteria:
- Age from 18 to 80 years old, man or non-pregnant woman;
- Subjects with stable or unstable angina, old myocardial infarction, or asymptomatic ischemic evidence with clinical diagnosis;
- Subjects without contraindications of coronary artery bypass grafting (CABG);
- Subjects must agree to the follow up of angiographic and clinical required in the study;
- Subjects are able to understand the purpose of this study, provide an informed consent to show recognize to the study protocol.
- 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);
- 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;
- Fulfill the definition of truly bifurcation lesions by Medina type (1.1.1、1.0.1、0.1.1);
- Diameter in side branch between ≥ 2.5 mm to ≤ 4.00 mm (visually) and lesion length ≤ 26 mm (visually);
- 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).
You may not qualify if:
- If subjects fulfill any of below criteria, this subject shall be exclude from this study.
- Pregnant or lactating women
- 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;
- Cardiogenic shock;
- Severe chronic heart failure, NYHA (New York Heart Association) ≥ grade III, or left ventricular ejection fraction \< 35% (accessed by echocardiography or left ventricular angiography)
- 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)
- 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;
- History of coronary or peripheral vascular interventional therapy within 12 months before hospitalized.
- Patients are allergic or contraindicate to contrast agent, paclitaxel, heparin, antiplatelet and anticoagulant drug;
- The Subjects have other serious diseases and the expected survival is less than 12 months;
- Investigators determine the subjects' compliance is poor, cannot complete the study as required;
- Main branch lesion or non-target lesion(s) located in left main;
- Main branch lesion or non-target lesion(s) is triple vessel lesion, all need to be treated;
- Side branch lesion is triple bifurcation or multiple bifurcation;
- 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);
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaling Han, professor
The General Hospital of Northern Theater Command
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2019
First Posted
January 29, 2019
Study Start
March 1, 2019
Primary Completion
May 1, 2022
Study Completion
October 1, 2022
Last Updated
January 31, 2019
Record last verified: 2019-01