Status:
UNKNOWN
The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
Lead Sponsor:
CCRF Inc., Beijing, China
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ba...
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 succes...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03820622
Start Date
March 1 2019
End Date
October 1 2022
Last Update
January 31 2019
Active Locations (13)
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1
Daqing Oil General Hospital
Daqing, Heilongjiang, China
2
Wuhan Asian Heart Hospital
Wuhan, Hubei, China
3
Nanjing First Hospital
Nanjing, Jiangsu, China
4
First Bethune Hospital of Jilin University
Changchun, Jilin, China