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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
Sponsor:
Information provided by (Responsible Party):
CCRF Inc., Beijing, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Device: Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) Device: Paclitaxel-Eluting Balloon (Bingo) Not Applicable

Detailed Description:
This is a prospective, multicenter, randomize, control and non-inferior study. 220 patients with bifurcation lesions will be randomized 1:1 to each group. after the main branch has been treated successfully, and if the side branch's stenosis is more than 70% and can be pre-dilated by POBA (plain old balloon angioplasty) successfully, then randomizing. the patients in the study group will be treated with paclitaxel-eluting coronary artery balloon dilatation catheter (DIOR), while those in the control group will be treated with paclitaxel-eluting balloon (Bingo). Clinical follow-up will be conducted at baseline, operation, hospital discharge, 1 month, 6 months, 9 months and 12 months after operation, and angiographic follow-up will be conducted at 9 months. The primary endpoint is late lumen loss (LLL) in the balloon dilatation coverage area of side branch of at 9 month after operation. The secondary endpoints include device success, clinical success, target lesion failure (TLF), target lesion revascularization (TLR), clinical composite endpoints and imaging endpoints. The information of adverse events, serious adverse events and device defects will be collected during the study.
Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. clinical success [ Time Frame: 1 month after operation ]
    define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success.

  3. 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)

  4. 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

  5. all cause death [ Time Frame: 1, 6, 9, 12 month after operation ]
    include cardiac death, vascular death, noncardiovascular death

  6. myocardial infarction (MI) [ Time Frame: 1, 6, 9, 12 month after operation ]
    target vessel MI, non-target vessel MI

  7. target lesion revasculation [ Time Frame: 1, 6, 9, 12 month after operation ]
    ischemic driven, non-ischemic driven

  8. target vessel revasculation [ Time Frame: 1, 6, 9, 12 month after operation ]
    ischemic driven, non-ischemic driven

  9. any coronary revasculation [ Time Frame: 1, 6, 9, 12 month after operation ]
  10. thrombosis in the side branch lesion [ Time Frame: 1, 6, 9, 12 month after operation ]

Other Outcome Measures:
  1. angiographic endpoints-late loss of side branch [ Time Frame: 9 months after operation ]
    assess in millimeter

  2. angiographic endpoints-minimal lumen diameter (MLD) of side branch [ Time Frame: 9 months after operation ]
    assess in millimeter

  3. angiographic endpoints-diameter stenosis (DS) [ Time Frame: 9 months after operation ]
    assess in percentage

  4. angiographic endpoints-angiographic binary restenosis (ABR) [ Time Frame: 9 months after operation ]
    assess in percentage


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Bing Wang, professor 86-024-28851120 wangbindl@hotmail.com
Contact: Geng Wang, professor 86-024-28851120 wanggeng69@163.com

Locations
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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   
Sponsors and Collaborators
CCRF Inc., Beijing, China
Investigators
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Principal Investigator: Yaling Han, professor General Hospital of Northern Theater Command
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CCRF Inc., Beijing, China:
coronary artery stenosis
drug eluting balloon
bifurcation
Additional relevant MeSH terms:
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Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action