Clinical trial NCT03820622: The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: coronary artery stenosis
drug eluting balloon
bifurcation
Lead sponsor: CCRF Inc., Beijing, China
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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;

Primary outcomes:
measure: late lumen loss
timeFrame: 9 months after operation
Secondary outcomes:
measure: device success
timeFrame: immediately post procedure
measure: clinical success
timeFrame: 1 month after operation
measure: device oriented composite endpoints (DoCE)
timeFrame: 1, 6, 9, 12 month after operation
measure: patients oriented composite endpoints (PoCE)
timeFrame: 1, 6, 9, 12 month after operation
measure: all cause death
timeFrame: 1, 6, 9, 12 month after operation
measure: myocardial infarction (MI)
timeFrame: 1, 6, 9, 12 month after operation
measure: target lesion revasculation
timeFrame: 1, 6, 9, 12 month after operation
measure: target vessel revasculation
timeFrame: 1, 6, 9, 12 month after operation
measure: any coronary revasculation
timeFrame: 1, 6, 9, 12 month after operation
measure: thrombosis in the side branch lesion
timeFrame: 1, 6, 9, 12 month after operation
Other outcomes:
measure: angiographic endpoints-late loss of side branch
timeFrame: 9 months after operation
measure: angiographic endpoints-minimal lumen diameter (MLD) of side branch
timeFrame: 9 months after operation
measure: angiographic endpoints-diameter stenosis (DS)
timeFrame: 9 months after operation
measure: angiographic endpoints-angiographic binary restenosis (ABR)
timeFrame: 9 months after operation
Locations:
city: Daqing
country: China
facility: Daqing Oil General Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Asian Heart Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: First Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian University
state: Liaonin
city: Shengyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaonin
city: Shengyang
country: China
facility: The First Hospital of China Medical University
state: Liaonin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Anzhen Hospital Capital Medical University
city: Shanghai
country: China
facility: Shanghai East Hospital,
city: Tianjin
country: China
facility: Tianjin Chest Hospital
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han, professor
role: PRINCIPAL_INVESTIGATOR
References: