The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions (BEYOND-II)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03820622 |
Recruitment Status :
Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 31, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Percutaneous Coronary Intervention | Device: Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) Device: Paclitaxel-Eluting Balloon (Bingo) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Estimated Study Start Date : | March 2019 |
Estimated Primary Completion Date : | May 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: DIOR group
in this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
|
Device: Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) |
Active Comparator: Bingo group
in this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo)
|
Device: Paclitaxel-Eluting Balloon (Bingo)
patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo) |
- late lumen loss [ Time Frame: 9 months after operation ]in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
- device success [ Time Frame: immediately post procedure ]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
- clinical success [ Time Frame: 1 month after operation ]define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success.
- device oriented composite endpoints (DoCE) [ Time Frame: 1, 6, 9, 12 month after operation ]that is TLF, define as the composite endpoint include cardiac death, target vessel myocardial infarction and ischemic driven target lesion revascularization (ID-TLR)
- patients oriented composite endpoints (PoCE) [ Time Frame: 1, 6, 9, 12 month after operation ]define as a composite endpoints of all cause death, any myocardial infarction and any revascularization
- all cause death [ Time Frame: 1, 6, 9, 12 month after operation ]include cardiac death, vascular death, noncardiovascular death
- myocardial infarction (MI) [ Time Frame: 1, 6, 9, 12 month after operation ]target vessel MI, non-target vessel MI
- target lesion revasculation [ Time Frame: 1, 6, 9, 12 month after operation ]ischemic driven, non-ischemic driven
- target vessel revasculation [ Time Frame: 1, 6, 9, 12 month after operation ]ischemic driven, non-ischemic driven
- any coronary revasculation [ Time Frame: 1, 6, 9, 12 month after operation ]
- thrombosis in the side branch lesion [ Time Frame: 1, 6, 9, 12 month after operation ]
- angiographic endpoints-late loss of side branch [ Time Frame: 9 months after operation ]assess in millimeter
- angiographic endpoints-minimal lumen diameter (MLD) of side branch [ Time Frame: 9 months after operation ]assess in millimeter
- angiographic endpoints-diameter stenosis (DS) [ Time Frame: 9 months after operation ]assess in percentage
- angiographic endpoints-angiographic binary restenosis (ABR) [ Time Frame: 9 months after operation ]assess in percentage

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects that participate in this study must fulfill all the following criteria:
General inclusion 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.
Angiographic inclusion criteria:
- 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).
Exclusion Criteria:
If subjects fulfill any of below criteria, this subject shall be exclude from this study.
General exclusion criteria:
- 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;
Angiographic exclusion criteria
- 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);
- Side branch target lesion is diffusion lesion and length > 26mm; or a ≥90% stenosis lesion is found near the SB lesion within 5 mm;
- Side branch as the target vessel has received any interventional treatment;
- Side branch as the target lesion or target vessel involve in aneurysm;
- The lesion in side branch or main branch is total occlusive lesions, with TIMI blood flow of grade 0;
- Side branch target lesion is moderate or heavy calcified or target vessel excessive tortuosity, which is unfavorable for interventional treatment anatomically;
- Subject's blood pressure is too low to be injected with nitroglycerin ≥ 100 ug, this subject can not be included in the study;
- 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820622
Contact: Bing Wang, professor | 86-024-28851120 | wangbindl@hotmail.com | |
Contact: Geng Wang, professor | 86-024-28851120 | wanggeng69@163.com |
China, Heilongjiang | |
Daqing Oil General Hospital | |
Daqing, Heilongjiang, China | |
Contact: Hui Li, professor 86-0459-5805310 | |
China, Hubei | |
Wuhan Asian Heart Hospital | |
Wuhan, Hubei, China | |
Contact: Xi Su, professor 86-027-65796888 yaxin_suxi@163.com | |
China, Jiangsu | |
Nanjing First Hospital | |
Nanjing, Jiangsu, China | |
Contact: Saoliang Chen, professor 86-025-52271351 chmengx@126.com | |
China, Jilin | |
First Bethune Hospital of Jilin University | |
Changchun, Jilin, China | |
China, Liaonin | |
The Second Hospital of Dalian University | |
Dalian, Liaonin, China | |
General Hospital of Northern Theater Command | |
Shengyang, Liaonin, China | |
Contact: Han Yaling, professor 86-024-28851120 hanyaling@263.net | |
Contact: Geng wang, professor 86-024-28851120 wanggeng69@163.com | |
The First Hospital of China Medical University | |
Shengyang, Liaonin, China | |
Contact: Yingxian Sun 86-024-83283166 | |
China, Yunnan | |
First Affiliated Hospital of Kunming Medical University | |
Kunming, Yunnan, China | |
China, Zhejiang | |
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | |
Hangzhou, Zhejiang, China | |
Contact: Guosheng Fu, professor 86-0571-86090073 fugs@medmail.com.cn | |
The Second Affiliated Hospital Zhejiang University School of Medicine | |
Hangzhou, Zhejiang, China | |
Contact: Wang jian'an, professor 86-0571-87783777 wangjianan@medmail.com.cn | |
China | |
Beijing Anzhen Hospital Capital Medical University | |
Beijing, China | |
Shanghai East Hospital, | |
Shanghai, China | |
Contact: Qi Zhang, professor 86-021-38804518 | |
Tianjin Chest Hospital | |
Tianjin, China | |
Contact: Hongliang Cong, professor 86-022-88185003 hongliangcong@163.com |
Principal Investigator: | Yaling Han, professor | General Hospital of Northern Theater Command |
Responsible Party: | CCRF Inc., Beijing, China |
ClinicalTrials.gov Identifier: | NCT03820622 |
Other Study ID Numbers: |
DIOR 2nd -1706 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | January 31, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
coronary artery stenosis drug eluting balloon bifurcation |
Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |