De Novo Coronary Bifurcation Lesions
Conditions
Interventions
The experimental group:paclitaxel-coated coronary balloon dilatation catheters manufactured by Nanjing Youdebang Medical Technology Co., Ltd.
the control group:drug-eluting balloon catheters (trade name: Qingzhou?) (Registration Certificate No.: National Medical Device Approval 20173031535) manufactured by Liaoning Inye Biotechnology Co., L
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 years 70%] and severe stenosis with non-typical myocardial ischemia symptoms [pre-dilatation target lesion branch vessel opening diameter stenosis >=90%], suitable for balloon angioplasty or stent implantation (3) Coronary angiography demonstrates the target lesion as a bifurcation lesion and the primary lesion (4) The main vessel is suitable for stenting; bifurcation lesions are not considered for dual-stenting and will undergo balloon angioplasty (5) Branch reference vessel diameter: 2.0–4.0 mm; lesion length <=36 mm (6) Voluntary participation in this study with signed written informed consent
Exclusion criteria
Exclusion criteria: (1) Grade C or higher dissection following pre-dilatation of the target lesion in a branch vessel, or presence of >30% residual stenosis or TIMI flow <3 (2) Angiography demonstrating extensive evidence of thrombus within the target vessel (3) Complete occlusion of the target vessel (4) Known severe fibrosis or calcification of the target lesion in a branch vessel, rendering adequate pre-dilatation unfeasible (5) Target lesion is a bifurcation lesion originating from the left main coronary artery (6) Myocardial infarction within 7 days prior to enrollment (7) Renal insufficiency (eGFR < 30 mL/min) or undergoing hemodialysis (8) White blood cell count < 3 × 10?/L or platelet count < 100 × 10?/L (9) Severe heart failure (LVEF < 35%) or NYHA Class IV cardiac function (10) Severe valvular heart disease precluding balloon angioplasty or stent implantation (11) Contraindications to antiplatelet or anticoagulant therapy, including drug allergies; major surgery, obstetric delivery, organ biopsy, or puncture procedures requiring non-compressible hemostasis within 14 days; history of gastrointestinal bleeding, cerebrovascular accident, diabetic hemorrhagic retinopathy within 6 months; or other medical history where prolonged antiplatelet therapy may be contraindicated (12) Known allergy to paclitaxel or iodinated contrast media (13) Ineligibility for coronary artery bypass grafting (14) Life expectancy <=1 year or anticipated difficulty completing 1-year follow-up (15) Pregnant or lactating women (16) Participation in other drug or device clinical trials (17) Other reasons deemed ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Diameter Stenosis of Target Lesions in Branch Vessels at 9 Months After Surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Device Performance;Incidence of device success, lesion success, and clinical success;Nine-month incidence of target lesion restenosis in branch vessels (=50% stenosis by angiography);Late lumen loss within the target lesion segment of the branch vessel at 9 months postoperatively;Target lesion revascularization (TLR) rates at 1, 6, 9, and 12 months postoperatively;Target Vessel Revascularization (TVR) Rate at 1, 6, 9, and 12 Months Postoperatively;Target lesion failure rate (TLF) at 1, 6, 9, and 12 months post-procedure;Major adverse cardiovascular events (MACE) incidence at 1, 6, 9, and 12 months post-procedure; Incidence of definite and probable target lesion coronary thrombosis at 1, 6, 9, and 12 months post-procedure; | — |
Countries
China
Contacts
Public ContactZhang Junfeng
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed