De Novo Coronary Bifurcation Lesions
Conditions
Interventions
Control Group:Paclitaxel-coated Balloon Catheter
Sponsors
First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: GeneralInclusion Criteria 1. Age >=18 years and =70% (by visual estimation) at the ostium of the target lesion side branch. 5. Successful pre-dilation/kissing balloon of the target lesion side branch, no dissection grade C olhigher, residual stenosis<=30% (by visual estimation) in the side branch lesion, and TlMl 3 fow 6. Suitable for PCl, with the main branch lesion of the target lesion planned for stent implantationwithout drug-coated balloon treatment, and the side branch lesion treated with a drug-coatedballoon without stent implantation; it is recommended to perform kissing balloon dilation for boththe main and side branches. 7. Reference diameter of the target lesion side branch 2.0-4.0 mm, and lesion length <=38 mm.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1. Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia 2. Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class lV). 3. Preoperative Renal lmpairment: Or currently undergoing hemodialysis treatment. 4. Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy. 5. History of Peptic Ulcer or Gastrointestinal Bleeding within the Past 6 Months: Or history of cerebralhemorrhage, cerebral infarction, or other cerebrovascular accidents (stroke) within the past 6months. 6. Known Allergies to Contrast Agents, Paclitaxel, Sirolimus, or Their Derivatives. 7. Life Expectancy Less Than 12 Months. 8. Poor Compliance: Participants who, in the investigator's judgment, are unlikely to adhere to thestudy requirements or are otherwise deemed unsuitable for inclusion. 9. Participation in Other Onaoina Clinical Trials: Participants who have not reached the primary endpoint in other ongoing clinical trials. 10. Pregnant or Lactating Women: Women who plan to conceive within 12 months or are unwilling touse effective contraception. Angiographic Exclusion Criteria 1. Left Main Trunk and lts Bifurcation Lesions Requiring Treatment. 2. Thrombus in the Target Lesion: Excessive tortuosity of the vessel, making it unlikely for the balloonto pass through the lesion. 3. Total Occlusion in the Side Branch Lesion of the Target Lesion. 4. Severe Calcification in the Side Branch Lesion of the Target Lesion: Lesions that cannot be pre-dilated or treated with double-balloon kissing dilation. 5. In-Stent Restenosis in the Target Vessel (including Both Main and Side Branches). 6. Residual Stenosis >30% (by Visual Estimation) or Dissection Grade C or Higher After Pre-Dilation orDouble-Balloon Kissina Dilation of the Side Branch Lesion of the Target Lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of stenosis (%) of target bifurcation lesion segment diameter at 9 months postoperatively (Measured by QCA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success;Lesion success;Procedural success;Incidence of Patient-oriented Compound Endpoints (PoCE) endpoints at 1, 6, 9, and 12 months postoperatively;Late luminal loss (LLL) within the target lesion device at 9 months postoperatively;Incidence of adverse events and serious adverse events related to the investigational device during the trial period;Incidence of all adverse events and serious adverse events during the trial period.;Degree of stenosis (%) of target lesion diameter at 9 months postoperatively;Degree of stenosis (%) of target lesion diameter at 9 months postoperatively; | — |
Countries
China
Contacts
Public ContactBai Ming
First Hospital of Lanzhou University
Outcome results
None listed