This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary bifurcation lesions.
Patients aged between 18 and 85 years, regardless of gender.
Patients must voluntarily participate in the study and sign an informed consent form.
Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days).
Patients must have evidence of myocardial ischemia.
Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention.
Patients with severe renal insufficiency (creatinine level > 3.0 mg/dL or 265.2 µmol/L) and/or end-stage renal disease requiring dialysis.
Patients in cardiogenic shock.
Patients who have experienced a myocardial infarction within the week prior to enrollment.
Parallel
Sirolimus coated balloon angioplasty
Combination productThis study involves the use of a Sirolimus-Coated Balloon (SCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The SCB is coated with sirolimus, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, providing a potential alternative to stent placement.
Paclitaxel coated balloon angioplasty
Combination productThis study involves the use of a Paclitaxel-Coated Balloon (PCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The PCB is coated with paclitaxel, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, providing a potential alternative to stent placement.
Diameter stenosis (%)
Percentage of target vessel stenosis per angiographic measurement at 6 months follow up
Interventional success rate
Including device success, lesion success, and clinical success Device Success: Includes successful delivery of the device and successful treatment. Successful Delivery: Successful delivery of the designated device to the lesion and release, with the delivery system retracting smoothly. Successful Treatment: Immediately post-procedure, residual stenosis of the target lesion is less than 50% with TIMI grade 3 flow (visual assessment). Lesion Success: After any interventional treatment, residual stenosis of the target lesion is less than 50% with TIMI grade 3 flow (visual assessment). Clinical Success: Based on lesion success, no major adverse cardiac events occurred during hospitalization (up to 7 days post-procedure).
Quantitative Flow Ratio (QFR)
In the presence of stenotic lesions in the coronary artery, the ratio of the maximum blood flow that the artery can deliver to the myocardial region to the maximum blood flow that could theoretically be obtained in that region under normal conditions.
Rate of restenosis
Coronary angiography results showing a diameter stenosis of ≥50% are considered indicative of restenosis.
Late lumen loss (LLL)
The difference between the minimum lumen diameter of the target lesion segment immediately post-procedure and the minimum lumen diameter of the same segment during the angiographic follow-up at 9 months post-procedure.
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Dongguan TT Medical
Lead sponsor
Peking University First Hospital
Collaborator
