AzTrials
AzTrials

Percutaneous Coronary InterventionBEYOND-IINCT03820622

The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions

A study testing Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) and Paclitaxel-Eluting Balloon (Bingo) in people with Percutaneous Coronary Intervention, run by CCRF Inc., Beijing, China at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Percutaneous Coronary Intervention
What is being tested?
Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) and Paclitaxel-Eluting Balloon (Bingo)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
13 sitesChina
Study dates
Mar 2019to Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 13Show fewer
  • 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).

Who cannot join

  • 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)
Show all 25Show fewer
  • 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;

Trial locations and contacts

13 sites in 1 country.

Bing Wang, professor contact

86-024-28851120

wangbindl@hotmail.com

Geng Wang, professor contact

86-024-28851120

wanggeng69@163.com

13 sites in 1 country

China13 sites

  • Beijing Anzhen Hospital Capital Medical University

    Beijing

  • First Bethune Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Dalian University

    Dalian, Liaoning

  • Daqing Oil General Hospital

    Daqing, Heilongjiang

    Hui Li, professor, 86-0459-5805310

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Guosheng Fu, professor, 86-0571-86090073, fugs@medmail.com.cn

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Wang jian'an, professor, 86-0571-87783777, wangjianan@medmail.com.cn

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Nanjing First Hospital

    Nanjing, Jiangsu

    Saoliang Chen, professor, 86-025-52271351, chmengx@126.com

  • Shanghai East Hospital,

    Shanghai

    Qi Zhang, professor, 86-021-38804518

  • General Hospital of Northern Theater Command

    Shengyang, Liaoning

    Han Yaling, professor, 86-024-28851120, hanyaling@263.net

    Geng wang, professor, 86-024-28851120, wanggeng69@163.com

  • The First Hospital of China Medical University

    Shengyang, Liaoning

    Yingxian Sun, 86-024-83283166

  • Tianjin Chest Hospital

    Tianjin

    Hongliang Cong, professor, 86-022-88185003, hongliangcong@163.com

  • Wuhan Asian Heart Hospital

    Wuhan, Hubei

    Xi Su, professor, 86-027-65796888, yaxin_suxi@163.com

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR), Paclitaxel-Eluting Balloon (Bingo)
Keywords
coronary artery stenosis, drug eluting balloon, bifurcation
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)Device

    patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)

  • Paclitaxel-Eluting Balloon (Bingo)Device

    patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)

Study groups in NCT03820622
Study groupRoleWhat they receive
DIOR groupExperimentalin this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
Receives: Device: Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
Bingo groupActive comparatorin this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo)
Receives: Device: Paclitaxel-Eluting Balloon (Bingo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. late lumen loss

    in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)

    Measured: 9 months after operation

Secondary outcomes (10)

  1. 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

    Measured: immediately post procedure

  2. clinical success

    define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success.

    Measured: 1 month after operation

  3. 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)

    Measured: 1, 6, 9, 12 month after operation

  4. patients oriented composite endpoints (PoCE)

    define as a composite endpoints of all cause death, any myocardial infarction and any revascularization

    Measured: 1, 6, 9, 12 month after operation

  5. all cause death

    include cardiac death, vascular death, noncardiovascular death

    Measured: 1, 6, 9, 12 month after operation

  6. myocardial infarction (MI)

    target vessel MI, non-target vessel MI

    Measured: 1, 6, 9, 12 month after operation

  7. target lesion revasculation

    ischemic driven, non-ischemic driven

    Measured: 1, 6, 9, 12 month after operation

  8. target vessel revasculation

    ischemic driven, non-ischemic driven

    Measured: 1, 6, 9, 12 month after operation

  9. any coronary revasculation

    Measured: 1, 6, 9, 12 month after operation

  10. thrombosis in the side branch lesion

    Measured: 1, 6, 9, 12 month after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study startMar 2019 (estimated)
  3. Primary completionMay 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03820622
Sponsor's protocol ID
DIOR 2nd -1706
Acronym
BEYOND-II
Status last verified
Jan 2019
First submitted
24 Jan 2019
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) and Paclitaxel-Eluting Balloon (Bingo) in people with Percutaneous Coronary Intervention, run by CCRF Inc., Beijing, China at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bing Wang, professor (86-024-28851120, wangbindl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

late lumen loss (time frame: 9 months after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03820622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in